EUCTR2010-022092-65-DE
Active, not recruiting
Phase 1
A phase IIa, randomized, double-blind (subject and investigator blind, sponsor open) placebo-controlled trial to evaluate the safety, tolerability and antiviral activity of oral ACH-0141625 in combination with pegylated interferon alfa-2a and ribavirin in two segments, after 28 days of dosing and, subsequently, after 12 weeks of dosing in subjects with chronic hepatitis C virus genotype 1.
ConditionsHepatitis C Virus Genotype 1MedDRA version: 14.0Level: LLTClassification code 10019751Term: Hepatitis C virusSystem Organ Class: 10022891 - InvestigationsMedDRA version: 14.0Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Hepatitis C Virus Genotype 1
- Sponsor
- Achillion Pharmaceuticals, Inc.
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Males and females aged 18 years or older
- •2\. Chronic HCV infection, documented by one of the following:
- •positive for anti\-HCV antibody, HCV RNA, or an HCV genotype at least 6 months before screening, and positive for HCV RNA and anti\-HCV antibody at the time of screening;
- •or positive for anti\-HCV antibody and HCV RNA at the time of screening with a liver biopsy consistent with chronic HCV infection (or a liver biopsy performed before enrollment with evidence of CHC disease, such as the presence of fibrosis).
- •3\. HCV genotype 1 (including 1a, 1b or mixed 1a/1b); subjects with mixed genotypes (e.g. 1/2, 1/3, etc.) or other genotypes (e.g. 2, 3, 4, 5, or 6\) will be excluded.
- •4\. Females who are post\-menopausal and amenorrheic must have an FSH measurement at screening with results in the post\-menopausal range for the central laboratory. Females of childbearing potential or surgically sterilized females must have a negative pregnancy test at screening and baseline. Females must use a non\-hormonal method of contraception and must agree not to get pregnant during the study and for six months following the discontinuation of standard of care.
- •5\. Fertile males, defined as all males physiologically capable of fathering offspring, may be enrolled in this study. Males in this category must agree to use a condom and his female partner must agree to use one or more methods of contraception from the date of screening until 6 months after their last dose of RBV. Males must not donate sperm while enrolled in this study and for three months following the last exposure to RBV
- •6\. Signed and dated written informed consent form
- •7\. Willing to participate in all study activities (including the ability to safely self\-inject study drug subcutaneously) and all study requirements (including effective contraception) during study period
- •8\. Treatment naïve subjects
Exclusion Criteria
- •1\. Body Mass Index (BMI) \> 36
- •2\. Pregnant or nursing (lactating) females, confirmed by a positive hCG laboratory test or females contemplating pregnancy. Men whose female partners are pregnant or contemplating pregnancy.
- •3\. Participation in any interventional clinical trial within previous 35 days.
- •4\. History of participation in a clinical trial with a protease inhibitor or previous treatment with a protease inhibitor, where at least one dose of the protease inhibitor was consumed.
- •5\. Use of herbal or homeopathic products, illicit drugs, CYP3A4/5 substrates, inducers or inhibitors (See Appendix 8\), hormonal methods of contraception, corticosteroids, immunosuppressives, or cytotoxic agents within 28 days of first dose of study drug.
- •6\. History of poor compliance with health and treatment regimens.
- •7\. Have a clinically significant laboratory abnormality at screening:
- •Absolute neutrophil count (ANC) \<1,500 / mm2 (1\.5 x 109/L)
- •Platelets \<90,000/mm2 (90 x 109/L)
- •Hemoglobin \<13 g/dL for males; \<12 g/dL for females
Outcomes
Primary Outcomes
Not specified
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