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Clinical Trial Question
Quick question for the HBV community.
On my other post I received a suggestion that if my sAg is very low at the end of my 24 week trial I should keep up the INF for a bit to increase odds of a seroconversion.
However, NIH would want to follow me for 48 weeks AFTER I go off INF. If I continue INF I would need to go off the trial (which is FINE with me). My father, though is saying that if I ever wanted to enroll in another future trial I'd have a "black mark" against me and they'd refuse to enroll me.
Does this have ANY merit at all? I told him that clinical trials work solely on inclusion criteria and exclusion. It's not like a credit report when you're applying for a loan. And it's not like there's some black list of patients that left trials early for whatever reason.
Am I crazy for thinking I'd have no issue enrolling in a future trial as long as I met the inclusion criteria? It's not like they wouldn't have data on me - it would just end at the 24 week mark instead of the 24+48 mark.
On my other post I received a suggestion that if my sAg is very low at the end of my 24 week trial I should keep up the INF for a bit to increase odds of a seroconversion.
However, NIH would want to follow me for 48 weeks AFTER I go off INF. If I continue INF I would need to go off the trial (which is FINE with me). My father, though is saying that if I ever wanted to enroll in another future trial I'd have a "black mark" against me and they'd refuse to enroll me.
Does this have ANY merit at all? I told him that clinical trials work solely on inclusion criteria and exclusion. It's not like a credit report when you're applying for a loan. And it's not like there's some black list of patients that left trials early for whatever reason.
Am I crazy for thinking I'd have no issue enrolling in a future trial as long as I met the inclusion criteria? It's not like they wouldn't have data on me - it would just end at the 24 week mark instead of the 24+48 mark.
The doctor will never release those numbers. That's patient confidentiality. I need to worry about this current trial first.
Ok, but have you asked what was HBsAg count of those patients ? I guess doctor doesnt know cuz no test in US :(
Maybe ask your doctor about some combo trial when you'll finish current trial.
Maybe ask your doctor about some combo trial when you'll finish current trial.
Genotype D, which is one that my doctor tried on for a few patients and it did not work at all. I can't constantly go do things like this, especially when not readily available by any lab here. It's too costly. Even traveling to another country is too costly for me right now, considering I'm close to broke...but that's another story lol As for the combo therapy, like it was mentioned here, I'm in the USA and PEG is different here, etc.
It can't hurt to try to get into the study. You're probably going to want to be local to the study center, though since it requires fairly regular visits to NIH.
With such low HBsAg quant you are perfect candidate for combo therapy. Where you gonna do next quant test ? Maybe it falled down more, since your are on nucs. Do you know your genotype ?
Funny that you mention all this. My doctor is one of the few doctors who did the combo therapy. Not all patients were cured, but a couple were. He side the side effects were not good for many (He didn't get into details) and would not prescribe it to me in the future due to low seroconversion percentage and the sides.
Also, I was going back from my first lab in 2014 and I noticed that the very first one, they actually did take HBsAg Quantitive and it was at 1764. It was then noted on the bottom:
"This test was developed and it's performance characteristics determined by the lab. It has not been cleared or approved by the Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary"
Take that for what you will. I have my own comments which I'll keep to myself :)
Also, I was going back from my first lab in 2014 and I noticed that the very first one, they actually did take HBsAg Quantitive and it was at 1764. It was then noted on the bottom:
"This test was developed and it's performance characteristics determined by the lab. It has not been cleared or approved by the Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary"
Take that for what you will. I have my own comments which I'll keep to myself :)
Does the trial offer hbsag quantitative test?
They are still accepting patient. Any reason no to enroll?
They are still accepting patient. Any reason no to enroll?
I actually think your trial is very interesting. Mark Ghany is certainly a well known HBV researcher. The roles of prolonged suppression of serum hbvdna (by oral antiviral), serum HBsAg, and Interferon in bringing about possible clearance of HBsAg are not clear. Your clinical trial seems to want to examine the role of Interferon, especially its effect on ISG, to try to get some answers.Other immunological factors are also to be examined. This may inform when and for how long to use Interferon in an optimal strategy.
Just my opinion.
Just my opinion.
This all looks like a big corruption thing..
1. They don't do HBsAG quantification at all - its seems it is even forbidden to do it if i understand it right...
2. I might be wrong but it seems like some group of researchers was pushing for a study of combo therapy, however the guys from above sabotaged it and approved it only for 24 months - knowing 24 month is not sufficient to reap the real benefits.
1. They don't do HBsAG quantification at all - its seems it is even forbidden to do it if i understand it right...
2. I might be wrong but it seems like some group of researchers was pushing for a study of combo therapy, however the guys from above sabotaged it and approved it only for 24 months - knowing 24 month is not sufficient to reap the real benefits.
This is very good information to know. If that's the case I may be stuck going back on TDF solo after this trial is over. Which is not horrible given how effective TDF is at at least keeping everything in check (except sAg).
Hopefully at some point in the near future somebody wakes up and realizes that sAg IS a valuable test. I'm currently looking into a lab just across the border in Mexico that I've heard could maybe do the test. I contacted them earlier today.
I actually contacted our insurance company today and they did say that TDF will be tough to get but with enough push should be fine. Haven't asked about INF yet.
Hopefully at some point in the near future somebody wakes up and realizes that sAg IS a valuable test. I'm currently looking into a lab just across the border in Mexico that I've heard could maybe do the test. I contacted them earlier today.
I actually contacted our insurance company today and they did say that TDF will be tough to get but with enough push should be fine. Haven't asked about INF yet.
I'm in the U.S. too and actually there is a good chance you may have a hard time getting INF paid for by he insurance company, and that is if you can find a doctor who will even prescribe it. The reason is because on almost all insurance plans in the U.S. they have INF as a specialty medication which will require a prior authorization, basically reason and supporting documents on why it's necessary and if you qualify for them to cover it. I would call your insurance company to find out what the coverage is for INF before you start planning, you may be in for a rude awakening.
Even TDF may need a prior authorization (mine didn't but many plans I have found it to need a PA), but of course TDF will be prescribed and recommended by your doctor, which shouldn't be that difficult to get it pushed through.
I'm a health insurance agent and looked into where you are now. The U.S. is NOT for INF for HBV (told due to harsh sides and low conversion rates) and both the doctors and insurance companies make it very hard. I have yet to meet a U.S. Hepatologst that is pro and will prescribe INF. I will push much harder (if nothing else comes available) if we can ever get our quant Ag tested.
Even TDF may need a prior authorization (mine didn't but many plans I have found it to need a PA), but of course TDF will be prescribed and recommended by your doctor, which shouldn't be that difficult to get it pushed through.
I'm a health insurance agent and looked into where you are now. The U.S. is NOT for INF for HBV (told due to harsh sides and low conversion rates) and both the doctors and insurance companies make it very hard. I have yet to meet a U.S. Hepatologst that is pro and will prescribe INF. I will push much harder (if nothing else comes available) if we can ever get our quant Ag tested.
Healthcare plan that I am on in the USA here *should* cover the combo therapy. If there's an issue it would seem it will be with getting the TDF rather than the INF.
not a good trial it is only for them to study we already know 24 weeks are so little on the otherhand i think nhs in uk does not cover peg plus tdf
https://www.clinicaltrials.gov/ct2/show/NCT02364336?term=hepatitis+b&recr=Open&rank=61
That is the link to the trial
That is the link to the trial
What is the sense to make a trial like this ? What is the target expectation of that trial ?
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