Trying to get into a clinical trial

I have had Hep C for about 2 1/2 years, Genotype 1a, and a low viral load.  I have an appt. this tues. 6/23, to see if I can get into a clinical trial for treatment.  The doctor that I talked to at this particular research site said that they were starting 5 new studies this summer for treatment naive patients.  I don't know which trials these are yet, but I am really hoping to get into a study that uses one of the protease inhibitors, since I heard that they have had a lot of success with them.  Does anyone have any advise for me going into this?  I really have high hopes that I will respond to treatment the first time around.

[annieCinMD]

They are very promising, and they do look for 1a's and 1b's for these trials. I am in one. I cleared after 2 weeks on the study drug. Unfortunately for me, I did a crossover arm and had done 16 weeks of SOC prior to receiving the 2 study drugs. My bloodwork took a nosedive after not quite 4 weeks on the PIs and I was told not to take any more meds until further notice. I didn't respond very well to SOC and it made me feel pretty lousy. I guess the other two added to the cocktail put me over the edge. But they worked!  Good luck getting into one, and getting in the right arm.

[Bill1954]

Hi Judy,

I don't have much advice for you; I had to treat two times, and both of them were with inteferon/ribavirin off the shelf; I'm done now, though. If you haven't already, you can look through this site for more info, including incluion and exclusion criteria:

http://clinicaltrials.gov/

[Bill1954]

Wow; I sent that one before it's time; I forgot to wish you good luck--

Bill

[ouc]

Hi Judy. I was on a trial  at the end of  the last  year.. (telaprevir + riba + interferon) for naive patients. I had taken the drugs just for six weeks and I have cleared the virus. I am 8 months post tx and I am SVR. Go for it.

[Gee704]

Wow I am so happy for your quick and complete response. When you say six weeks; was it six weeks only on all medications or six weeks with the telaprevir and longer on the riba and interferon?

[lapis]

I am also a Geno 1b.  I completed 24 wks of tx in a tx-naive study using Telaprevir (for the first 8-12 wks) + SOC.  That was 10 wks ago.  I was UND at 4 wks post EOT.

There are lots of great things about being in trials.  The doctor's visits and meds are all free, and they even gave me coupons for the parking garage : ).  The care I received was excellent, as is the follow-up care.  I will continue to have study visits and labs done at 12 wks, 24 wks, and 48 wks after finishing tx.

So here are the things to be aware of:  In receiving tx from a private hepatologist, if you become severely anemic on tx (which is one of the sides of both Ribavirin and Telaprevir), or if your WBC count becomes too low, you will be able to take medication to treat the anemia or low WBC, and keep taking the weight-based dose of Ribavirin.  These are called "rescue drugs" so you'll want to know whether rescue drugs are available on your trial.  

Although I did become very anemic (Hgb down to 9.1), rescue drugs were not used in my trial, and my Ribavirin dose was reduced for most of my tx.  This concerned me, esp after reading a lot on this site, but I guess with the PI it worked out okay.

My trial caregivers were very hesitant about sharing my own labs with me.  Apparently at other sites this was not the case, but it was very frustrating for me.  Neither they nor I were able to access my viral load (PCR) info until the 4 wk post EOT visit (since the trial was double-blinded), but I was interested in thyroid levels, WBC and RBC counts, and they basically only told me when something was low or I asked a question.  I asked for copies of labs at times and they were reluctant to give me this data, saying it belonged to VTX.

If treating privately, you'd want to have a PCR done 4 wks and 12 wks into your tx, to know how you're responding.  All I knew was what I could infer:  if I'm still in the study, I must be responding.  It was challenging to march on through my tx without that knowledge, but I had great faith in the PI.

Many studies will require a liver biopsy in the year prior to beginning tx.  Because my liver bx had been done more than a year before (17 months) I was required to undergo another liver bx before being accepted into the study.

What else?  Please let me know if you have more questions, and best of luck as you go forward.

Lapis

[lapis]

Oh, yes, the most obvious thing....Geno 1's usually treat for 48 wks, with the PI's tx can sometimes be completed in 24 wks, depends of course on your response to tx, but that's a huge benefit, to be able to tx in half the time.

Also, in a study, you won't know what group you're in.  Although I was certain I got the study drug, I didn't really KNOW for sure.  There are others here who have had some not-so-good experiences being in studies, maybe they will chime in with more things for you to consider.

[annieCinMD]

Not all trial's are "blinded", like the one lapis was in. I know I got the study drug, and what arm I am in. However, with the exception of crossing over after my 12 week results, I didn't get to choose. I got put in arm 1, and at that point was told I was on straight SOC. At the cross over point, I know I got the 2 study drugs, and how much I am getting. I am in the SCH 900518 trial (Schering Plough). If you can get in one of the Schering Plough studies, I'd recommend it. My study coordinator said they are the best. She has worked on several others and Schering is very compassionate about their patients. If you do end up in a placebo arm, they will provide the real treatment at a later point. Some kind of voucher.

[Rockerforlife]

The 518 trial is the best one to watch....this is the one that will drive stocks sky high

[annieCinMD]

More info on the 518 trial. If it goes into part 2, which is not randomized, you will automatically go in Arm 7, which is the study drug for 12 weeks, after a 4 week "priming" with SOC. This would be a very good option to get into! I think I got primed too much with 16 weeks of SOC. I was starting to break down by the point the study drugs were introduced. Now I have to wait and see what happens. They could stop my treatment altogether. Right now I'm stopped until further bloodwork is done. Rocker, aren't you almost done? I thought you might get randomed out at 36 weeks. Just curious how you make out.

[Rockerforlife]

just blasted away # 33 shot...maybe 3 more boosters to go

[Rockerforlife]

Strange thing is i dont feel the shots at all,nothing..not even ay red marks....am i super man?

[Rockerforlife]

My life may be chaniging soon...its possible...what happens if  get cured,go to college,get a good trade,by the time im finished school the economic crisis shold be abaded ,get a better job with more pay,...only one thing holding me back....will the TX affect my thinking processes,my body is fine...maybe my brain will take the brunt ...im thinkn postive here...if this happens....i know for a fact GOD does indeed exist.

[Judy0212]

Thanks to all of of you for the info., advice, and good luck wishes!  My appointment is this tues. and I've been praying a lot that I get into a study, and that I get into a good arm of a study -so that I will get the investigational drug as well as SOC.  I am both excited and nervous --not knowing what will happen. I am a nurse, so I have a lot of medical knowledge and actually have taken care of many Hep C patients on a liver transplant unit, plus I've read a lot on my own.  I just know that I never want to go down the road that some of my patients went down--ESLD is not a pretty thing!  

I feel like I have a good chance of kicking this thing and am counting on God and my PMA (positive mental attitude) to get me through it. I know it will be a tough year -- I have heard that the side effects can be bad but I am willing to endure anything to get rid of this!  

To all of you who have kicked this thing --that's awesome, and very encouraging!!  I hope I will be able to post my success story in the months to come!

Judy

[Judy0212]

On the Clinical Trials.gov website it looks like the Schering 900518 study is being conducted at my study site, so that is exciting!  I will definitely ask about this one! Looks to me like I would meet all of the inclusion criteria too.   I know they will have to do a liver biopsy since I haven't had one yet but I expect my liver to be in fine shape because I take care of myself and I've only had the virus for 2 1/2 years.   Thanks for the "heads up"!!  I will follow-up with another post after my appt. this week to let you all know what happened.

[newleaf09]

Rocker, you are not the only person who had no sides from shot!  Initially it freaks you out and you think you didn't do the shot right but actually, we were just fabulously lucky not to react.  I was also highly responsive to interferon.  Go figure.

Judy,
There are differences between Phase 2 and Phase 3 trials.  They know drug works but are still trying to pinpoint the perfect dose and dosing time in a Phase 2.  That's a pretty good opportunity.  A Phase 3, however, is just extra proof that they were right and that's a fabulous opportunity.

There are also differenced between a Schering Plough trial and a Vertex trial.  The Shcering phase 3 boceprevir PI trial going on now was blinded (no one but the computer knew which arm you were in) but info on your PCR's and bloodwork was immediately available.  Procrit, to bring up your hemoglobin levels was provided by the study.  You could generally tell you were on the boceprevir instead of placebo because it made an odd taste in your mouth and a little gastric disturbance. You did not find out till 28 wks. if you were going to finish early, then just walked out of clinic with no meds.  The Vertex phase 3 teleprevir PI trial, also going on now, concealed PCR info from patients, but smartest ones had them done on the side by their own doctors.  It's hard to be encouraged when no one tells you you're doing great. They also discouraged the use of Procrit and anti-depressants (common side effect of interferon).  It was harder to tell if you were on teleprevir instead of placebo.  They told you at the 24 wk. visit if you were going to get to stop at 28 wks.  Both PI's are showing great results.

There are more side effects with a 3rd drug.  DEFINITELY clearly ask if any rescue drugs will be provided if necessary (they are very expensive).  IF you get into a 28 wk. arm, even though there may be a few more side effects, you will get off of all drugs 20 weeks earlier than regular treatment.  That's a really good thing.

One other issue, besides the overwhelming diiference in cost to patient, darn near everything is free in the trial (x-rays, biopsies, cat scans, all), is the level of attention you get in a trial.  I was in the boceprevir trial (and did excellent in 28 wks. except for side effects; still waiting out the 6 mo. PCR that determines cure) and had issues briefly with my treatment team.  When I thought of dropping out and finishing with my private doctor, I knew that I could never have the access to my private doc that I have with the study team.  I have the nurse's private cell phone # and call or text her with any problem.  Can't beat that.

See all trials at www.clinicaltrials.gov . Search for hepatitis C, then narrow by using the map function to find the trials near you.  I recommend Phase 3 trials; probably Phase 2's also.

[Judy0212]

Thanks for all of the info. --that definitely gives me some things to ask about when I go for my appt. on tues.  I am hoping for a very good experience with this study team, because I work in an office that has a research dept. and a couple of the girls who work study there used to work study at the Liver Institute where I am going for my study appt.  They gave me the phone number of the provider to contact and assured me that she was great, and would take wonderful care of me.  I actually already talked to her on the phone and she was very nice, and helpful.  I appreciate the info.you have shared.  I am working on my list of questions to take with me, so you have given me some more things to ask.  Thanks!

Judy

[ouc]

Let me elaborate on my TX. That was Phase 3 Study with Telaprevir in combination with Peginterferon alfa 2a(Pegasys) and Ribavirin (Copegus) in Treatment_Naive Subjects with Genotype 1 . It was Double Blinded Study. I had Geno 1b, 1mill VL, stage 1. The Tx supposed to last 24 or 48 weeks . There were 3 groups in the Study. Each group received PEG + RBV  but only two of the 3 groups received TELAPREVIR. MY CASE.I didn't now what group I was assign to. So every day for the six weeks I took RBV TELAPREVIR or PLACEBO and once a week INTERFORON. In week Four I was told I am responding well to the TX. In week Six I hit  the bottom rock. I developed depression, anxiety, severe anemia. (my Hemoglobin went down to 7.4) I wasn't allow to take any extra medication for my condition. They just decreased my RBV. That was it. Anyway I culdn't take it anymore so I just dropped the TX. Didn't hope for any positive outcome. After all I didn't complete my TX, I didn't even know if I was in Telaprevir arm. Two months later I went to my doctor (not a study Doctor) to check my VL and I got a nice surprise from him , I was UND. 8 moths later I am still UND. Looks like I am clear at this point. I  must have taken  THE TELAPREVIR. I will know what arm I was assigned to after they unblind the Study  next year.

[lapis]

You wrote:  

"The Vertex phase 3 teleprevir PI trial, also going on now, concealed PCR info from patients, but

smartest ones had them done on the side by their own doctors. "

Excuse me, but having PCR's done on the side has nothing to do with intelligence.  My PMD knew I was in a double-blinded clinical trial and he refused to do a private PCR, citing ethical reasons.  I looked into ordering the test online and paying cash for it, but the cost was over $600, a bit much for my pocketbook.    

Also "They told you at the 24 wk. visit if you were going to get to stop at 28 wks."  
No, they told me at the 24 wk visit that I would stop tx that week, not at 28 wks.

"They also discouraged the use of Procrit and anti-depressants."
My tx team put me on AD's after the first wk of tx, when I described feeling anxious, irritable, snappish, having a nervous energy.  They also increased my dose when that was needed.  But you're right about the Procrit, it was not available to study participants..

[newleaf09]

Thanks lapis.  I wasn't in the teleprevir trial so can only present what I've gathered from others.

There is an incredible amount of variation between the study sites, also.  They seem to inject a little of their own philosophy into what's best for their patients.  My boceprevir study team was stingey with the procrit, making your hgb drop below 10 and cutting you off when you went over 10.  Others I heard from kept their patients at 11 and handed out procrit like party favors. Sure would have appreciated that; there's a huge difference between 10 and 11.  I've always wished we could put all of the trial protocols and experiences on this site, but I'm sure the pharmaceutical companies would object.  I mean, what is the purpose of concealing the PCR info from the patients?  Are they afraid that people who did well but get randomized to the 48 wk TX period will just quit at 28 wks. and mess up the study data?  I found the PCR info incredibly encouraging and anxiety relieving.  If they had to stop or reduce my meds (never the trial drug of course), the next clear PCR reassured me that it was okay.

Sounds like Judy may be lucking into a good team to work with.

[annieCinMD]

Maybe there is hope for me, if they end up pulling me out altogether. My situation is a bit similar to yours. I have been told to cease all meds until further bloodwork can be done at my next appointment on June 30. I think I actually got 4 weeks of the 2 study drugs under my belt, not 3.5. I keep confusing it with my injection day (Friday). I actually started the 2 study drugs mid-week, like on a Wednesday. Looks like I got in a full 4 weeks. I completely fell apart, too, and still am not feeling that much better after 3 full days off the meds. Less thirsty and more hungry is about it, but I guess it's a start!

[susan400]

Is this Schering '518' trial a protease trial or a polymerase trial??  Just curious.  Still keep my mind open to the future, whatever happens, happens, you know?  Just trying to stay healthy.  Susan400

[newleaf09]

From clinicaltrials.gov:

SCH 900518 is a potent oral inhibitor of HCV NS3 protease which disrupts hepatitis C virus (HCV) polyprotein processing.

I believe I have heard it called a second generation (or next generation) protease inhibitor and early trials showed it more effective than the first gens, boceprevir and teleprevir.

[Judy0212]

Well, I had my first appointment today and I'm very encouraged by what I learned.  The NP/PhD that I met with wants to try to get me into the new Schering 900518 trial coming up in the next few weeks --whenever Schering gives them the word to go forward with it.  That was very exciting to me because of all the trials I have researched, that was my "favorite" ...it seems to be the most promising, and potential for shorter treatment (28 weeks)!!!  She told me that when they got the word, they would call their prospective candidates in for screening and that I needed to drop everything I was doing and get down there!  I said "no problem" I will be there double time!!  I feel sure that I will pass the screening, because I am very healthy other than the Hep C, plus being a healthcare professional, I know how important compliance is and I assured her that I would be the most compliant patient she's ever had!

I am very excited and anticipate good things here in the next few weeks,
and will let everyone know more about what's happening as things develop!!

[Isobella]

Good for you, Judy.  My doc had good things to say about that trial, also.

Keep asking questions and please keep us posted.

[Judy0212]

OK, I came up with a question, that I'm not sure of the answer.  At the point in treatment that the virus becomes undetectable, is your blood still considered "contagious" because you're still in treatment, or would it be impossible to spread the virus at that point because it is "undetectable" ?  Just curious  ...I would think that if there is no virus, then you would not be able to infect anyone else with your blood.  Anyone know for sure????

[annieCinMD]

I'm inclined to go with your thoughts on being able to infect others. I wouldn't think if you are UND that you could not infect anyone through your blood. That's just an educated guess, though.