Chronic Hepatitis C Clinical Trial
Official title:
Phase 2a Study of Boceprevir for the Treatment of Genotype 6 Hepatitis C
The purpose of this study is to evaluate the antiviral efficacy of Boceprevir-based therapy
for the treatment of genotype 6 chronic hepatitis C infection.
Boceprevir has recently been approved for the treatment of genotype 1 chronic hepatitis C
infection. Recent in vitro studies suggest similar efficacy against genotype 6 chronic
hepatitis C infection.
The investigators therefore hypothesise that:
i) Boceprevir is a potent inhibitor of genotype 6 hepatitis C replication in vivo.
ii) Boceprevir in combination with pegylated interferon-alpha and ribavirin for 24 weeks
will cure a high proportion of patients chronically infected with genotype 6 chronic
hepatitis C infection.
Genotype 6 HCV (HCV-6) is common in parts of South-East Asia, in particular Vietnam. There
is a small but growing population of immigrant patients with chronic HCV-6 in Australia. The
current standard-of-care treatment (SOC) for chronic HCV-6 infection is peg-interferon-α
(PEG-IFN) and ribavirin (RBV) therapy for 48 weeks. The available data evaluating treatment
outcome suggests that SVR rates are intermediate between those of HCV-1 and HCV-2/3. There
is a medical need for novel therapies that might increase SVR rates and/or allow shortened
treatment duration.
Boceprevir is a novel HCV NS3 protease inhibitor, and boceprevir-based triple therapy has
recently been approved for the treatment of HCV-1. Boceprevir also appears to have some
antiviral effect against HCV-2 and HCV-3 in vivo. Boceprevir has not been used to treat
patients with chronic HCV-6 infection. Recent in vitro data have demonstrated that
boceprevir has an antiviral effect against HCV-6.
The investigators are therefore undertaking an investigator-initiated proof-of-concept pilot
study of boceprevir-based therapy for the treatment of patients chronically infected with
HCV-6.
The study population will consist of a representative group of 30 adult patients who are
chronically infected with genotype 6 HCV. All patients will be of Asian background, will be
non-cirrhotic, and will carry a "good response" IL28B genotype (C/C for rs12979860). The
patients will be recruited from the outpatient clinics of 4 Hepatology units in Melbourne,
Australia, represented by the principal and associate investigators.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01937975 -
The Pharmacokinetics of Grazoprevir (MK-5172) and Elbasvir (MK-8742) in Participants With Renal Insufficiency (MK-5172-050)
|
Phase 1 | |
| Completed |
NCT03673696 -
The Tolerability and Pharmacokinetics Study of HEC74647PA Capsule in Healthy Adult Subjects
|
Phase 1 | |
| Completed |
NCT02250001 -
Asunaprevir/Daclatasvir Safety Surveillance in Japanese Patients With Chronic Hepatitis C
|
N/A | |
| Completed |
NCT03088917 -
'Fibrosis in the Lost Hepatitis C Population - Track, Trace and Treat'
|
||
| Completed |
NCT02207088 -
Ombitasvir/ABT-450/Ritonavir and Dasabuvir With or Without Ribavirin in HCV Genotype 1-Infected Adults With Chronic Kidney Disease
|
Phase 3 | |
| Not yet recruiting |
NCT02865369 -
Regression of Liver Fibrosis After Daclatasvir and Asunaprevir Treatment
|
N/A | |
| Recruiting |
NCT02638233 -
Therapy With Ledipasvir/Sofosbuvir in Patients With Genotype 1 HCV Infection Receiving Opiate Substitution Therapy
|
Phase 4 | |
| Not yet recruiting |
NCT02511496 -
Status of Chronic Liver Disease in Hepatitis C Virus (HCV) Patients Coinfected With Human Immunodeficiency Virus (HIV) in Andalusia
|
N/A | |
| Completed |
NCT02788682 -
Association of Vitamin D Binding Protein Polymorphisms With Response to HCV Therapy
|
N/A | |
| Completed |
NCT01439776 -
Add Vitamin D With Standard of Care for Chronic Hepatitis C Patients
|
Phase 4 | |
| Recruiting |
NCT01360892 -
Prediction of Incidence of Liver Cancer by Use of Real-time Tissue Elastography
|
N/A | |
| Recruiting |
NCT01360879 -
Assessment of Liver FIBROsis by Real-time Tissue ELASTography in Chronic Liver Disease
|
N/A | |
| Terminated |
NCT00962936 -
Safety and Tolerability Study of the Monoclonal Antibody CT-011 in Patients With Chronic Hepatitis C Genotype I Infection
|
Phase 1/Phase 2 | |
| Completed |
NCT00968357 -
Proof-of-concept Study to Evaluate the Safety and Immunomodulatory Effects of SCV 07 as Monotherapy or in Combination With Ribavirin in Noncirrhotic Subjects With Chronic Hepatitis C Who Have Relapsed
|
Phase 2 | |
| Recruiting |
NCT00575627 -
Pegylated-Interferon and Ribavirin in Hepatitis C Patients With Persistently Normal Alanine Aminotransferase Levels
|
Phase 4 | |
| Recruiting |
NCT01178749 -
Exploration of Chronic Hepatitis C Infection Receiving 24-week Interferon-α With Ribavirin Treatments
|
N/A | |
| Completed |
NCT00537407 -
A Study of Debio 025 in Combination With PegIFN Alpha-2a and Ribavirin in Chronic HCV Patients Non-responders to Standard Treatment
|
Phase 2 | |
| Recruiting |
NCT00370617 -
Pegylated-Interferon and Ribavirin Plus Metformin in the Treatment of Chronic HCV Infection and Insulin Resistance
|
Phase 4 | |
| Completed |
NCT01684787 -
Study to Evaluate the Treatment for Chronic Hepatitis C With Normal Transaminases in HIV Positive Patients
|
Phase 4 | |
| Active, not recruiting |
NCT00225537 -
4-Methylumbelliferone as a Treatment for Chronic HBV/HCV
|
Phase 2 |