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Safety, Tolerability, and Antiviral Activity of ACH-0141625 or Placebo in Combination With Peginterferon and Ribavirin in Hepatitis C Virus (HCV) Positive Participants

NCT01180790 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2023-08-30

Study results available
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Summary

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

Conditions

  • Hepatitis C

Interventions

DRUG

ACH-0141625 (Sovaprevir)

200 mg oral capsule once daily

DRUG

ACH-0141625 (Sovaprevir)

400 mg oral capsule once daily

DRUG

ACH-0141625 (Sovaprevir)

800 mg oral capsule once daily

DRUG

Placebo

Powder in capsule once daily

DRUG

Pegylated Interferon alpha-2a

180 micrograms (ug) once a week by subcutaneous injection

DRUG

Ribavirin

400 mg or 600 mg (morning \[AM\]) and 600 mg (evening \[PM\]) capsules taken orally twice daily

Sponsors & Collaborators

  • Achillion, a wholly owned subsidiary of Alexion

    collaborator INDUSTRY

  • Alexion Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2012-03-31
Completion
2013-04-30

Countries

  • United States
  • Belgium

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01180790 on ClinicalTrials.gov