Genotype 4 Chronic Hepatitis C Infection Clinical Trial
Official title:
Pilot Study to Determine the Efficacy and Safety of Combining Boceprevir With Peginterferon Alfa-2b and Ribavirin in the Treatment-naive Patients Infected With Genotype 4 Chronic Hepatitis C Infection
| Verified date | December 2014 |
| Source | Theodor Bilharz Research Institute |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Hypothesis Combination of Boceprevir with Ribavirin in treatment-naïve patients with genotype 4 chronic hepatitis C infection will increase the proportion of patients achieving sustained viral response compared to standard treatment alone.
| Status | Unknown status |
| Enrollment | 40 |
| Est. completion date | December 2015 |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
- Ages Eligible for Study: 18 Years and older - Genders Eligible for Study: Both Inclusion Criteria: - Subject must be more than 18 years of age. - Subject's weight must be more than 40 kg and less than 125 kg. - Subject and subject's partner must each agree to use acceptable methods of contraception for at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study medication, or longer if dictated by local regulations. - Subjects must be willing to give written informed consent for the trial and for the pharmacogenetic testing. - Subjects who are unwilling to provide written informed consent for pharmacogenetic testing may be included in the trial; however, pharmacogenetic samples must not be obtained. - Subject must have previously documented CHC genotype 4 infection. - Subjects with other or mixed genotypes are not eligible. The HCV-RNA result obtained from the central laboratory at the screening visit must confirm genotype 4 infection and be more10,000 IU per mL Previously untreated patients with Pegylated interferon - Subject must have a liver biopsy or fibrotest and fibroscan with histology consistent with CHC and no other etiology. Exclusion Criteria: - Subject who is coinfected with the human immunodeficiency virus (HIV) or hepatitis B virus. - Prior treatment with interferon, ribavirin and/or investigational agent for hepatitis C. - Prior treatments with herbal remedies with known hepatotoxicity are exclusionary. - All herbal remedies used for hepatitis C treatment must be discontinued before Day 1. - Treatment with any investigational drug within 30 days of the screening visit in this trial. - Subject who received any of the following medication(s) within 2 weeks prior to the Day 1 visit that are highly dependent on CYP3A4.5 for clearance, and for which elevated plasma concentrations are associated with serious and or life-threatening events such as: orally administered midazolam, pimozide, amiodarone, flecainide, propafenone, quinidine and ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine). - Evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy. |
| Country | Name | City | State |
|---|---|---|---|
| Egypt | Theodor Bilharz Research Institute | Giza |
| Lead Sponsor | Collaborator |
|---|---|
| Theodor Bilharz Research Institute |
Egypt,
Poordad F, McCone J Jr, Bacon BR, Bruno S, Manns MP, Sulkowski MS, Jacobson IM, Reddy KR, Goodman ZD, Boparai N, DiNubile MJ, Sniukiene V, Brass CA, Albrecht JK, Bronowicki JP; SPRINT-2 Investigators. Boceprevir for untreated chronic HCV genotype 1 infection. N Engl J Med. 2011 Mar 31;364(13):1195-206. doi: 10.1056/NEJMoa1010494. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Efficacy | The primary efficacy objective of this study is to assess the efficacy of Boceprevir in combination with PEG 1.5 µg/kg QW SC plus WBD of RBV (800 to 1400 mg/day) compared to the efficacy of SOC (therapy with PEG+RBV WBD) in the Control Arm in previously untreated adult subjects with CHC genotype 4 infection | 72 Weeks | |
| Secondary | Week 8 Response | 1. Assess the number of patients who achieved SVR after achieving undetectable or =2 log reduction of HCV RNA level at treatment week 8; | 8 weeks | |
| Secondary | 12 Weeks response | Assess the number of patients who achieved SVR after achieving undetectable or =2 log reduction of HCV RNA level at treatment week 12 | 12 weeks | |
| Secondary | IL-28B polymorphism | To evaluate the effect of IL-28B polymorphism (CC,CT,TT) alleles on the viral kinetic response after the addition of Boceprevir | 72 Weeks |