- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01180790
Safety, Tolerability, and Antiviral Activity of ACH-0141625 or Placebo in Combination With Peginterferon and Ribavirin in Hepatitis C Virus (HCV) Positive Participants
August 7, 2023 updated by: Alexion
A Phase IIa, Randomized, Double-blind (Participant 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 Alpha-2a and Ribavirin in Two Segments, After 28 Days of Dosing and, Subsequently, After 12 Weeks of Dosing in Participants With Chronic Hepatitis C Virus Genotype 1
Evaluate safety, tolerability, and antiviral response of ACH-0141625 compared to standard of care in hepatitis C virus (HCV)-positive participants.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
122
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Antwerp
-
Edegem, Antwerp, Belgium, 2650
- Clinical Trial Site
-
-
Hainaut
-
Haine-Saint-Paul, Hainaut, Belgium, 7100
- Clinical Trial Site
-
-
Oost-Vlaanderen
-
Gent, Oost-Vlaanderen, Belgium, 9000
- Clinical Trial Site
-
-
-
-
California
-
Los Angeles, California, United States, 90036
- Clinical Trial Site
-
Los Angeles, California, United States, 90048
- Clinical Trial Site
-
San Francisco, California, United States, 94115
- Clinical Trial Site
-
-
Florida
-
Bradenton, Florida, United States, 34209
- Clinical Trial Site
-
Orlando, Florida, United States, 32803
- Clinical Trial Site
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Clinical Trial Site
-
-
Kansas
-
Overland Park, Kansas, United States, 66211
- Clinical Trial Site
-
-
Missouri
-
Saint Louis, Missouri, United States, 63104
- Clinical Trial Site
-
-
Nevada
-
Las Vegas, Nevada, United States, 89106
- Clinical Trial Site
-
-
New York
-
New York, New York, United States, 10065
- Clinical Trial Site
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19141
- Clinical Trial Site
-
-
Texas
-
Arlington, Texas, United States, 76012
- Clinical Trial Site
-
San Antonio, Texas, United States, 78215
- Clinical Trial Site
-
-
Virginia
-
Newport News, Virginia, United States, 23602
- Clinical Trial Site
-
Norfolk, Virginia, United States, 23502
- Clinical Trial Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
|
200 mg oral capsule once daily
400 mg oral capsule once daily
800 mg oral capsule once daily
180 micrograms (ug) once a week by subcutaneous injection
Other Names:
400 mg or 600 mg (morning [AM]) and 600 mg (evening [PM]) capsules taken orally twice daily
Other Names:
|
Experimental: Segment 1: 400 mg ACH-0141625
400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks
|
200 mg oral capsule once daily
400 mg oral capsule once daily
800 mg oral capsule once daily
180 micrograms (ug) once a week by subcutaneous injection
Other Names:
400 mg or 600 mg (morning [AM]) and 600 mg (evening [PM]) capsules taken orally twice daily
Other Names:
|
Experimental: Segment 1: 800 mg ACH-0141625
800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks
|
200 mg oral capsule once daily
400 mg oral capsule once daily
800 mg oral capsule once daily
180 micrograms (ug) once a week by subcutaneous injection
Other Names:
400 mg or 600 mg (morning [AM]) and 600 mg (evening [PM]) capsules taken orally twice daily
Other Names:
|
Placebo Comparator: Segment 1: Placebo
Placebo for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks
|
Powder in capsule once daily
180 micrograms (ug) once a week by subcutaneous injection
Other Names:
400 mg or 600 mg (morning [AM]) and 600 mg (evening [PM]) capsules taken orally twice daily
Other Names:
|
Experimental: 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
|
200 mg oral capsule once daily
400 mg oral capsule once daily
800 mg oral capsule once daily
180 micrograms (ug) once a week by subcutaneous injection
Other Names:
400 mg or 600 mg (morning [AM]) and 600 mg (evening [PM]) capsules taken orally twice daily
Other Names:
|
Experimental: 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
|
200 mg oral capsule once daily
400 mg oral capsule once daily
800 mg oral capsule once daily
180 micrograms (ug) once a week by subcutaneous injection
Other Names:
400 mg or 600 mg (morning [AM]) and 600 mg (evening [PM]) capsules taken orally twice daily
Other Names:
|
Experimental: 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
|
200 mg oral capsule once daily
400 mg oral capsule once daily
800 mg oral capsule once daily
180 micrograms (ug) once a week by subcutaneous injection
Other Names:
400 mg or 600 mg (morning [AM]) and 600 mg (evening [PM]) capsules taken orally twice daily
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Segment 1: Safety
Time Frame: 4 weeks
|
Segment 1: Percentage of participants with the following: adverse events, abnormal laboratory safety tests, dose reductions, interruptions, and discontinuations.
Criteria for abnormal laboratory safety tests: treatment-emergent worsening Division of AIDS (Acquired Immunodeficiency Syndrome) (DAIDs) graded laboratory tests.
A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
|
4 weeks
|
Segment 1: Rapid Viral Response At Week 4 (RVR4)
Time Frame: 4 weeks
|
The primary efficacy endpoint for Segment 1 of the study was the percentage of participants in each treatment group achieving RVR4 (hepatitis C virus [HCV] ribonucleic acid (RNA) less than or equal to the limit of quantitation [LOQ] at the Week 4 visit).
|
4 weeks
|
Segment 2: Safety
Time Frame: 12 weeks
|
Segment 2: Percentage of participants with the following: adverse events, abnormal laboratory safety tests and dose reductions, interruptions and discontinuations.
Criteria for abnormal laboratory safety tests: treatment-emergent worsening DAIDs graded laboratory tests.
A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
|
12 weeks
|
Segment 2: Complete Early Virologic Response (cEVR)
Time Frame: Week 12
|
The primary efficacy endpoint for Segment 2 of the study was the percentage of participants achieving cEVR, defined as undetectable HCV RNA at Week 12.
|
Week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Segment 1: cEVR
Time Frame: 12 weeks
|
For Segment 1, the percentage of participants in the virology population who achieved cEVR, defined as undetectable HCV RNA at Week 12.
|
12 weeks
|
Segment 2: RVR4
Time Frame: 4 weeks
|
For Segment 2, the percentage of participants in the virology population who achieved RVR4, defined as HCV RNA less than or equal to the LOQ at the Week 4 visit.
|
4 weeks
|
Segment 1 And Segment 2: End Of Treatment Response
Time Frame: Week 48 (Segment 1); Week 24 (Segment 2)
|
The percentage of virology population participants who were reported as undetectable HCV RNA at the completion of treatment.
|
Week 48 (Segment 1); Week 24 (Segment 2)
|
Segment 1 And Segment 2: Sustained Virologic Response 12 Weeks (3 Months Post-dosing) (SVR12)
Time Frame: 3 months post-dosing
|
The percentage of virology population participants who achieved sustained virologic response (SVR), defined as HCV RNA less than the LOQ, at 12 weeks (3 months) post-dosing.
|
3 months post-dosing
|
Segment 1 And Segment 2: Sustained Virologic Response 24 Weeks (6 Months Post-dosing) (SVR24)
Time Frame: 6 months post-dosing
|
The percentage of virology population participants who achieved SVR, defined as HCV RNA less than the LOQ, 6 months post-dosing.
|
6 months post-dosing
|
Segment 1 And Segment 2: HCV RNA Change From Baseline
Time Frame: Week 4
|
The mean change from baseline in log10 HCV RNA level by visit for the virology population
|
Week 4
|
Segment 1 And Segment 2: HCV RNA Change From Baseline
Time Frame: Week 12
|
Change from baseline in log10 HCV RNA level by visit.
|
Week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Hetal Kocinsky, MD, Alexion Pharmaceuticals
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (Actual)
March 1, 2012
Study Completion (Actual)
April 1, 2013
Study Registration Dates
First Submitted
August 11, 2010
First Submitted That Met QC Criteria
August 11, 2010
First Posted (Estimated)
August 12, 2010
Study Record Updates
Last Update Posted (Actual)
August 30, 2023
Last Update Submitted That Met QC Criteria
August 7, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis
- Hepatitis A
- Hepatitis C
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Antimetabolites
- Antineoplastic Agents
- Immunologic Factors
- Interferons
- Interferon-alpha
- Ribavirin
- Peginterferon alfa-2a
- Interferon alpha-2
Other Study ID Numbers
- ACH625-003
- 2010-022092-65 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hepatitis C
-
Tripep ABInovio PharmaceuticalsUnknownChronic Hepatitis C Virus InfectionSweden
-
Hadassah Medical OrganizationXTL BiopharmaceuticalsWithdrawnChronic Hepatitis C Virus InfectionIsrael
-
Hadassah Medical OrganizationUnknownChronic Hepatitis C Virus InfectionIsrael
-
AbbVieCompletedChronic Hepatitis C | Hepatitis C (HCV) | Hepatitis C Genotype 1a
-
AbbVie (prior sponsor, Abbott)CompletedChronic Hepatitis C | Hepatitis C Genotype 1 | Hepatitis C (HCV)United States, Australia, Canada, France, Germany, New Zealand, Puerto Rico, Spain, United Kingdom
-
AbbVieCompletedHepatitis C Virus | Chronic Hepatitis C Virus
-
AbbVie (prior sponsor, Abbott)CompletedHepatitis C | Chronic Hepatitis C Infection | HCV | Hepatitis C Genotype 1United States
-
Trek Therapeutics, PBCCompletedChronic Hepatitis C | Hepatitis C Genotype 1 | Hepatitis C (HCV) | Hepatitis C Viral InfectionUnited States, New Zealand
-
Trek Therapeutics, PBCCompletedChronic Hepatitis C | Hepatitis C (HCV) | Hepatitis C Genotype 4 | Hepatitis C Viral InfectionUnited States
-
Beni-Suef UniversityCompletedChronic Hepatitis C Virus InfectionEgypt
Clinical Trials on ACH-0141625 (Sovaprevir)
-
AlexionAchillion, a wholly owned subsidiary of AlexionCompletedHepatitis C, ChronicUnited States, Canada
-
Alexion PharmaceuticalsAchillion, a wholly owned subsidiary of AlexionCompleted
-
Alexion PharmaceuticalsAchillion, a wholly owned subsidiary of AlexionCompletedHealthy | Renal DysfunctionUnited States
-
Alexion PharmaceuticalsAchillion, a wholly owned subsidiary of AlexionCompleted
-
Alexion PharmaceuticalsAchillion, a wholly owned subsidiary of AlexionCompleted
-
Alexion PharmaceuticalsAchillion, a wholly owned subsidiary of AlexionCompletedParoxysmal Nocturnal Hemoglobinuria (PNH)United Kingdom, New Zealand, Korea, Republic of, Italy
-
AlexionAchillion, a wholly owned subsidiary of AlexionCompletedParoxysmal Nocturnal HemoglobinuriaNew Zealand, Korea, Republic of, Italy
-
Alexion PharmaceuticalsAchillion, a wholly owned subsidiary of AlexionCompleted
-
Alexion PharmaceuticalsAchillion, a wholly owned subsidiary of AlexionCompleted
-
Alexion PharmaceuticalsCompleted