HCV Infection Clinical Trial
Official title:
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Comparing 24 or 48 Weeks of GS 9190, in Combination With Peginterferon Alfa 2a and Ribavirin, to 48 Weeks of Peginterferon Alfa 2a and Ribavirin for the Treatment of Genotype-1 Chronic Hepatitis C Virus (HCV) Infection (GS-US-196-0103)
The purpose of this study is to compare the safety, tolerability and effectiveness of the experimental drug GS-9190 when administered for 24 or 48 weeks with peginterferon alfa 2a and ribavirin for the treatment of genotype-1 chronic hepatitis C infection.
The safety, tolerability and antiviral efficacy GS-9190, administered orally twice daily at
40 mg, will be compared to placebo when used in combination with peginterferon alfa 2a (PEG)
and ribavirin (RIBA) in treatment-naïve subjects chronically infected with HCV genotype 1
infection. Two-hundred forty-eight (248) subjects will be randomized (ratio: 1:2:1) to one
of three treatment arms:
Arm 1: PEG/RIBA + placebo BID for 48 weeks + 24 weeks treatment-free follow-up (n = 62)
Arm 2: PEG/RIBA + GS 9190 40 mg BID for 48 weeks + 24 weeks treatment-free follow-up (n =
124)
Arm 3: PEG/RIBA + GS 9190 40 mg BID for 48 weeks + 24 weeks treatment-free follow-up.
However, subjects who achieve RVR (HCV RNA undetectable at Week 4) and maintain that
response through Week 24 will stop all study drugs at Week 24 and be followed for an
additional 48 weeks (n = 62).
Randomization will be stratified by plasma HCV RNA level (< or ≥ 400,000 IU/mL) at screening
and race (of African descent or other).
In order to ensure adequate representation of subjects with genotypes 1a and 1b in this
trial, enrollment for either genotype will be capped at 120 subjects. Once 120 subjects of
either genotype (e.g., genotype 1a) have been randomized, subsequent enrollment will only be
allowed for subjects with the other genotype (e.g., genotype 1b).
The duration of double-blind treatment is 48 weeks plus 24 weeks of treatment-free
follow-up; however subjects in Arm 3 will stop all medication at Week 24 if they have
achieved an RVR (defined by undetectable HCV RNA following 4 weeks on therapy) and have
maintained that response thereafter. Subjects will only learn that they have been randomized
to Arm 3 if, at Week 24, having achieved criteria for stopping therapy, they are instructed
to stop. All other subjects will remain blinded to their treatment status throughout the
course of the study.
The standard of care treatment stopping criterion used in clinical practice when treating
HCV with PEG/RIBA, failure to achieve EVR, will be utilized in this trial. Additionally,
subjects with detectable plasma HCV RNA at Week 24 will discontinue all study medications no
later than the Week 28 visit and will be followed off-treatment for 24 weeks.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03674125 -
Evaluation of Safety, Tolerability, and Immunogenicity Study of GLS-6150 in Healthy Volunteers and in Persons Previously Treated for Hepatitis C Virus Infection
|
Phase 1 | |
Completed |
NCT00978497 -
Safety, Tolerability, and Antiviral Activity of ANA598 Administered in Combination With Pegylated Interferon and Ribavirin for the Treatment of Genotype-1 Chronic HCV Infection
|
Phase 2 | |
Completed |
NCT00170131 -
MMF Influence on HCV Viral Evolution After Liver Transplantation
|
Phase 4 | |
Completed |
NCT04008927 -
A Community-based Intervention Among Active Drug Users in Montpellier
|
N/A | |
Active, not recruiting |
NCT04044586 -
HIV and HCV Infections in 2 Communes From the Battambang Province, Cambodia: Prevalence Rates, Viral Strains, and Unsafe Injection Practices (12352 ANRS ROK INVEST)
|
||
Completed |
NCT01958281 -
Sofosbuvir Plus Ribavirin, or Ledipasvir/Sofosbuvir in Adults With HCV Infection and Renal Insufficiency
|
Phase 2 | |
Completed |
NCT02533427 -
Study to Evaluate Effect of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination on the Pharmacokinetics of a Representative Hormonal Contraceptive Medication, Norgestimate/Ethinyl Estradiol
|
Phase 1 | |
Completed |
NCT02783976 -
Sovaldi-based Regimens in Patients in Mexico With Chronic Hepatitis C Virus Infection in Clinical Practice
|
||
Withdrawn |
NCT04309734 -
Study of AT-777 in Healthy Subjects and AT-777 in Combination With AT-527 in HCV-Infected Subjects
|
Phase 1/Phase 2 | |
Completed |
NCT01965535 -
Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination ± Ribavirin in Cirrhotic Subjects With Chronic Genotype 1 HCV Infection
|
Phase 2 | |
Completed |
NCT00768690 -
A Study in Healthy Adult Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of ABT-333
|
Phase 1 | |
Withdrawn |
NCT04235049 -
Elimination of HCV Through Linkage and In Prison Treatment of Incarcerated Populations (ECLIPSE)
|
Phase 4 | |
Terminated |
NCT00401947 -
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of ACH-0137171 in Participants With Chronic Hepatitis C Infection
|
Phase 2 | |
Completed |
NCT00959699 -
A Phase 2b, Safety and Efficacy Study of Boceprevir in Patients Coinfected With HIV and Hepatitis C (P05411 AM4)
|
Phase 2 | |
Completed |
NCT00623649 -
Safety,Tolerability and Pharmacokinetics of Multiple Ascending Doses of VCH 916 in Subjects With Chronic Hep C Infection
|
Phase 1 | |
Completed |
NCT00221624 -
Peginterferon Alfa-2a Plus Ribavirin Plus Amantadine for the Treatment of Hepatitis C Infected Patients
|
Phase 3 | |
Completed |
NCT04134767 -
Kentucky Communities and Researchers Engaging to Halt the Opioid Epidemic (CARE2HOPE)
|
N/A | |
Completed |
NCT02402452 -
Pharmacokinetics of Voxilaprevir in Adults With Normal Renal Function and Severe Renal Impairment
|
Phase 1 | |
Completed |
NCT00909311 -
Study in Healthy Adults to Evaluate Effect of Food on Pharmacokinetics, Safety and Tolerability of ABT-450 With Ritonavir
|
Phase 1 | |
Completed |
NCT00909636 -
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of the ABT-333 Tablet
|
Phase 1 |