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897070 tn?1320656229
Abbott Trial- Abt450/r+ Abt330+ Abt267+Rbv ?
Does anyone have any experience or knowledge of this interferon free trial from Abbott. Am considering taking part in the next phase of it but there are many questions that I need answers to before I even consider going ahead. The trial isn't due to start for a few months yet so am just trying to get a few opinions.

Cheers.
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Avatar universal
I know a lot of people on another site that have done this trial with great success. I'll send you a PM.
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446474 tn?1446351282
A Study of ABT-450 With Ritonavir and ABT-267 and/or ABT-333 With and Without Ribavirin in Genotype 1 HCV Infected Subjects

Verified by: Abbott, August 2012
First Received: September 28, 2011 | Last Updated: August 12, 2012
Phase: Phase 2 | Start Date: October 2011
Overall Status: Active, not recruiting | Estimated Enrollment: 560

Official Title: “A Randomized, Open Label, Multi-center Study to Evaluate the Antiviral Activity, Safety, and Pharmacokinetics, of ABT-450 With Ritonavir (ABT-450/r) in Combination With ABT-267 and/or ABT-333 With and Without Ribavirin (RBV) in Treatment-Naïve and Null Responder Subjects With Genotype 1 Chronic Hepatitis C Virus Infection”

This is a study of combination direct-acting antiviral agents (DAA) and/or Ribavirin (RBV) in subjects with chronic Hepatitis C Virus (HCV).

Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Primary Completion Date: January 2013
Detailed Clinical Trial Description

A study to evaluate the safety and effect of experimental drugs ABT-450, ABT-267, ABT-333, ritonavir, and Ribavirin in people with HCV. The study will test the safety and effects of combinations of these drugs in treatments up to 24 weeks.

Interventions Used in this Clinical Trial

Drug: ABT-450/r
ABT-450 (tablets) dosed with ritonavir (capsules)
Drug: ABT-333
ABT-333 (tablets)
Drug: ABT-267
ABT-267 (tablets)
Drug: Ribavirin (RBV)
Ribavirin (tablets)

Arms, Groups and Cohorts in this Clinical Trial

Experimental: Group A
ABT-450/r, ABT-267, ABT-333, Ribavirin (RBV) in combination

Experimental: Group B
ABT-450/r and ABT-333, RBV in combination

Experimental: Group C
ABT-450/r, ABT-267, RBV in combination

Experimental: Group D
ABT-450/r, ABT-267, RBV in combination

Experimental: Group E
ABT-450/r, ABT-267, ABT-333 in combination

Experimental: Group F
ABT-450/r, ABT-267, ABT-333, RBV in combination

Experimental: Group G
ABT-450/r, ABT-267, ABT-333, RBV in combination

Experimental: Group H
ABT-450/r, ABT-267, ABT-333, RBV in combination

Experimental: Group I
ABT-450/r, ABT-267, ABT-333, RBV in combination

Experimental: Group J
ABT-450/r, ABT-267, RBV in combination

Experimental: Group K
ABT-450/r, ABT-267, ABT-333, RBV in combination

Experimental: Group L
ABT-450/r, ABT-267, ABT-333, RBV in combination

Experimental: Group M
ABT-450/r, ABT-267, ABT-333, RBV in combination

Experimental: Group N
ABT-450/r, ABT-267, ABT-333, RBV in combination
Outcome Measures for this Clinical Trial

Primary Measures
Safety of all treatment regimens
Time Frame: Baseline to End of Active Treatment (up to 24 weeks)
Safety Issue?: Yes
Percentage of subjects achieving 24-week sustained virologic response (SVR24) following treatment with different durations of 3 DAAs (direct acting anti-virals) and RBV (ribavirin) in HCV (HepatitisC) genotype 1-infected treatment-naïve adults
Time Frame: Post Treatment Week 24
Safety Issue?: No

Secondary Measures
Percentage of subjects achieving SVR24 (HCV RNA < LLOQ at post-treatment Week 24) following treatment of different durations with 3 DAAs with RBV in treatment naïve and null responder subjects
Time Frame: Post-Treatment Week 24
Safety Issue?: No

Percentage of subjects achieving SVR24 (HCV RNA < LLOQ at post-treatment Week 24) following treatment with 3 DAAs with RBV versus 3 DAAs without RBV in treatment naïve subjects
Time Frame: Post-Treatment Week 24
Safety Issue?: No

Percentage of subjects achieving SVR24 (HCV RNA < LLOQ at post-treatment Week 24) following treatment with 2 DAAs with RBV versus 3 DAAs with RBV in treatment naïve and null responder subjects

Time Frame: Post-Treatment Week 24

Safety Issue?: No

Percentage of subjects achieving SVR24 (HCV RNA < LLOQ at post-treatment Week 24) following treatment with 3 DAAs with RBV in with different doses of ABT-450/r in treatment treatment naïve and null responder subjects

Time Frame: Post-Treatment Week 24

Safety Issue?: No

Any emerged or enriched mutations Post-Baseline by mixed population and/or clonal sequencing

Time Frame: Day 1 to Post-Treatment Week 48 or Premature Discontinuation

Safety Issue?: No
Criteria for Participation in this Clinical Trial

Inclusion Criteria

Males and females 18-70 years old, inclusive
Females must be post-menopausal for more than 2 years or surgically sterile or practicing specific forms of birth control
Chronic Hepatitis C Virus (HCV), genotype 1 infection
Treatment naive OR prior null-responders to previous treatment with pegylated interferon (pegIFN) and Ribavirin (RBV)
No evidence of liver cirrhosis

Exclusion Criteria
Positive screen for drugs and alcohol
Significant sensitivity to any drug
Use of contraindicated or prohibited medications within 1 month of dosing
Abnormal laboratory tests
Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial: No


Cheers!
Hector
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897070 tn?1320656229
thanks hector, hope all's well with you ?

Paul
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No exclusions due to OLT?
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Avatar universal
hi

first of all, i'm french, please pardon my english.:)

I did this trial this year for 12 weeks and this trial is over since 14 weeks.

since 23 weeks, hvc is undetectable in my blood.

I had ABT-450/r, ABT-267, ABT-333, RBV in combination

I had no side effects.

In my oppinion this trial was a great success.

regards
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897070 tn?1320656229
Thanks for that Remy, that's encouraging to know, do you know what drug doses you received or the clear rate of other people on your trial ?

Regards
Paul
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Hi

I belong to G group.

ABT-450/r (50 mg) 3 pills - 1 pill per day. Ritonavir (100 mg) 1 pill per day  
ABT-267 (25 mg) 1 pill per day
ABT-333 (400 mg) 2 pill twice per day.( Morning 1/ evening 1)
Ribavirin  (200 mg) 5 per day (morning 3 pill, evening 2 pills).

I don't know  other people doing the trial. Anyway, last time I talk to doctor at the hospital (2 weeks ago), they told me this trial had good results waether the Group.

Best regards.
Rémy
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I mean, whatever the group.
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