Safety, Tolerability and Antiviral Activity of ACH-0141625 or Placebo in Combination With Peginterferon and Ribavirin in HCV Positive Subjects

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Evaluate safety, tolerability and antiviral response of ACH-0141625 compared to Standard of Care in HCV positive subjects.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Achillion Pharmaceuticals; Alexion Pharmaceuticals
• Treatments: Antiviral Agents; Interferon alpha-2; Interferon-alpha; Interferons; Peginterferon alfa-2a; Ribavirin

Criteria

Inclusion Criteria:

• Males and females 18 years and older

• Chronic hepatitis C Genotype 1 (as specified in the protocol)

• Treatment naive

• Females who are post-menopausal and amenorrheic must have a FSH at screening. Females of child bearing potential 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 SOC.

• Fertile males must agree to use a condom and his female partner must agree to use one or more methods of contraception. Males must not donate sperm during the study and three months following the last exposure to RBV.

Exclusion Criteria:

• BMI >36 kg/m2

• Pregnant or nursing females: or females of childbearing potential not willing to comply with contraceptive measures per protocol. Men whose female partners are pregnant or contemplating pregnancy. - Coinfection with HBV and/or HIV

• Other significant disease including liver disease

• History of drug or alcohol dependence or addiction within the past 6 months

• 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.

• Use of herbal or homeopathic products, illicit drugs, cytochrome P450 (CYP 3A4/5 substrates, inducers or inhibitors, hormonal methods of contraception, corticosteroids, immunosuppressive, or cytotoxic agents within 28 days of first dose of study drug.

• Have a clinically significant laboratory abnormality at screening (as specified in protocol).

• Segment 1: Subjects with any history of decompensated liver disease defined as cirrhotic subjects with a Child-Pugh score of > or = to 7. Segment 2: Subjects who have had a liver biopsy that shows bridging fibrosis or cirrhosis.

• Nonalcoholic steatohepatitis if ballooning degeneration or Mallory bodies are present on liver biopsy.

• Subjects, who prematurely discontinued, interrupted or dose reduced prior Peg-IFN and Ribavirin therapy, due to noncompliance or safety issues.

• Encephalopathy or altered mental status of any etiology.

• History of moderate, severe or uncontrolled psychiatric disease (as specified in protocol).

• History of malignancy of any organ system treated or untreated within the past 5 years.

• Use of colony stimulating factor agents within 90 days prior to baseline.

• History of seizure disorder.

• History of known coagulopathy including hemophilia.

• Clinically of significant findings on fundoscopic or retinal examination at screening

• History of immunologically mediate disease.

• History of clinical evidence of chronic cardiac disease (as specified in protocol)

• Received concomitant systemic antibiotic, antifungals or antivirals for the treatment of active infection within 14 days prior to the first dose of the study drug (as specified in protocol)