Safety, Tolerability, and Antiviral Activity of ACH-0141625 or Placebo in Combination With Peginterferon and Ribavirin in Hepatitis C Virus (HCV) Positive Participants
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: ACH-0141625 (Sovaprevir); ACH-0141625 (Sovaprevir); ACH-0141625 (Sovaprevir); Placebo; Pegylated Interferon alpha-2a; Ribavirin
Intervention description: 200 mg oral capsule once daily; 400 mg oral capsule once daily; 800 mg oral capsule once daily; Powder in capsule once daily; 180 micrograms (ug) once a week by subcutaneous injection; 400 mg or 600 mg (morning [AM]) and 600 mg (evening [PM]) capsules taken orally twice daily
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 122.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HCV; Hepatitis C Genotype 1

Summary:

      Evaluate safety, tolerability, and antiviral response of ACH-0141625 compared to standard of
      care in hepatitis C virus (HCV)-positive participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females, aged 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 follicle-stimulating
             hormone (FSH) at screening. Females of childbearing 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 6 months
             following the discontinuation of standard of care (SOC).

          -  Fertile males must agree to use a condom and his female partner must agree to use 1 or
             more methods of contraception. Males must not donate sperm during the study and 3
             months following the last exposure to RBV.

        Exclusion Criteria:

          -  Body mass index (BMI) >36 kilograms (kg)/square meter (m^2)

          -  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 hepatitis B virus (HBV) and/or human
             immunodeficiency virus (HIV)

          -  Other significant diseases 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 1 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 the first
             dose of study drug.

          -  Have a clinically significant laboratory abnormality at screening (as specified in the
             protocol).

          -  Segment 1: Participants with any history of decompensated liver disease defined as
             cirrhotic participants with a Child-Pugh score of > or = to 7. Segment 2: Participants
             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.

          -  Participants who prematurely discontinued, interrupted, or dose reduced prior Peg-IFN
             and RBV 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 the
             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 the 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 the protocol)