Safety, Tolerability, and Antiviral Activity of ACH-0141625 or Placebo in Combination With Peginterferon and Ribavirin in Hepatitis C Virus (HCV) Positive Participants
NCT ID: NCT01180790
Last Updated: 2023-08-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
122 participants
INTERVENTIONAL
2010-09-30
2013-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Segment 1: 200 milligrams (mg) ACH-0141625
200 mg ACH-0141625 for 28 days plus pegylated interferon (Peg-IFN) alpha-2a and ribavirin (RBV) for 48 weeks
ACH-0141625 (Sovaprevir)
200 mg oral capsule once daily
Pegylated Interferon alpha-2a
180 micrograms (ug) once a week by subcutaneous injection
Ribavirin
400 mg or 600 mg (morning \[AM\]) and 600 mg (evening \[PM\]) capsules taken orally twice daily
Segment 1: 400 mg ACH-0141625
400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks
ACH-0141625 (Sovaprevir)
400 mg oral capsule once daily
Pegylated Interferon alpha-2a
180 micrograms (ug) once a week by subcutaneous injection
Ribavirin
400 mg or 600 mg (morning \[AM\]) and 600 mg (evening \[PM\]) capsules taken orally twice daily
Segment 1: 800 mg ACH-0141625
800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks
ACH-0141625 (Sovaprevir)
800 mg oral capsule once daily
Pegylated Interferon alpha-2a
180 micrograms (ug) once a week by subcutaneous injection
Ribavirin
400 mg or 600 mg (morning \[AM\]) and 600 mg (evening \[PM\]) capsules taken orally twice daily
Segment 1: Placebo
Placebo for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks
Placebo
Powder in capsule once daily
Pegylated Interferon alpha-2a
180 micrograms (ug) once a week by subcutaneous injection
Ribavirin
400 mg or 600 mg (morning \[AM\]) and 600 mg (evening \[PM\]) capsules taken orally twice daily
Segment 2: 200 mg ACH-0141625
200 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks
ACH-0141625 (Sovaprevir)
200 mg oral capsule once daily
Pegylated Interferon alpha-2a
180 micrograms (ug) once a week by subcutaneous injection
Ribavirin
400 mg or 600 mg (morning \[AM\]) and 600 mg (evening \[PM\]) capsules taken orally twice daily
Segment 2 : 400 mg ACH-0141625
400 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks
ACH-0141625 (Sovaprevir)
400 mg oral capsule once daily
Pegylated Interferon alpha-2a
180 micrograms (ug) once a week by subcutaneous injection
Ribavirin
400 mg or 600 mg (morning \[AM\]) and 600 mg (evening \[PM\]) capsules taken orally twice daily
Segment 2 : 800 mg ACH-0141625
800 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks
ACH-0141625 (Sovaprevir)
800 mg oral capsule once daily
Pegylated Interferon alpha-2a
180 micrograms (ug) once a week by subcutaneous injection
Ribavirin
400 mg or 600 mg (morning \[AM\]) and 600 mg (evening \[PM\]) capsules taken orally twice daily
Interventions
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ACH-0141625 (Sovaprevir)
200 mg oral capsule once daily
ACH-0141625 (Sovaprevir)
400 mg oral capsule once daily
ACH-0141625 (Sovaprevir)
800 mg oral capsule once daily
Placebo
Powder in capsule once daily
Pegylated Interferon alpha-2a
180 micrograms (ug) once a week by subcutaneous injection
Ribavirin
400 mg or 600 mg (morning \[AM\]) and 600 mg (evening \[PM\]) capsules taken orally twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Achillion, a wholly owned subsidiary of Alexion
INDUSTRY
Alexion Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Clinical Trial Site
Los Angeles, California, United States
Clinical Trial Site
Los Angeles, California, United States
Clinical Trial Site
San Francisco, California, United States
Clinical Trial Site
Bradenton, Florida, United States
Clinical Trial Site
Orlando, Florida, United States
Clinical Trial Site
Chicago, Illinois, United States
Clinical Trial Site
Overland Park, Kansas, United States
Clinical Trial Site
St Louis, Missouri, United States
Clinical Trial Site
Las Vegas, Nevada, United States
Clinical Trial Site
New York, New York, United States
Clinical Trial Site
Philadelphia, Pennsylvania, United States
Clinical Trial Site
Arlington, Texas, United States
Clinical Trial Site
San Antonio, Texas, United States
Clinical Trial Site
Newport News, Virginia, United States
Clinical Trial Site
Norfolk, Virginia, United States
Clinical Trial Site
Edegem, Antwerp, Belgium
Clinical Trial Site
Haine-Saint-Paul, Hainaut, Belgium
Clinical Trial Site
Ghent, Oost-Vlaanderen, Belgium
Countries
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Other Identifiers
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2010-022092-65
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ACH625-003
Identifier Type: -
Identifier Source: org_study_id
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