Safety, Tolerability, and Antiviral Activity of ACH-0141625 or Placebo in Combination With Peginterferon and Ribavirin in Hepatitis C Virus (HCV) Positive Participants
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
2 other identifiers
interventional
122
2 countries
18
Brief Summary
Evaluate safety, tolerability, and antiviral response of ACH-0141625 compared to standard of care in hepatitis C virus (HCV)-positive participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2010
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2010
CompletedFirst Posted
Study publicly available on registry
August 12, 2010
CompletedStudy Start
First participant enrolled
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedResults Posted
Study results publicly available
September 10, 2014
CompletedAugust 30, 2023
August 1, 2023
1.5 years
August 11, 2010
July 29, 2014
August 7, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Segment 1: Safety
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)
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
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)
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 Outcomes (7)
Segment 1: cEVR
12 weeks
Segment 2: RVR4
4 weeks
Segment 1 And Segment 2: End Of Treatment Response
Week 48 (Segment 1); Week 24 (Segment 2)
Segment 1 And Segment 2: Sustained Virologic Response 12 Weeks (3 Months Post-dosing) (SVR12)
3 months post-dosing
Segment 1 And Segment 2: Sustained Virologic Response 24 Weeks (6 Months Post-dosing) (SVR24)
6 months post-dosing
- +2 more secondary outcomes
Study Arms (7)
Segment 1: 200 milligrams (mg) ACH-0141625
EXPERIMENTAL200 mg ACH-0141625 for 28 days plus pegylated interferon (Peg-IFN) alpha-2a and ribavirin (RBV) for 48 weeks
Segment 1: 400 mg ACH-0141625
EXPERIMENTAL400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks
Segment 1: 800 mg ACH-0141625
EXPERIMENTAL800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks
Segment 1: Placebo
PLACEBO COMPARATORPlacebo for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks
Segment 2: 200 mg ACH-0141625
EXPERIMENTAL200 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks
Segment 2 : 400 mg ACH-0141625
EXPERIMENTAL400 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks
Segment 2 : 800 mg ACH-0141625
EXPERIMENTAL800 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks
Interventions
200 mg oral 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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Clinical Trial Site
Los Angeles, California, 90036, United States
Clinical Trial Site
Los Angeles, California, 90048, United States
Clinical Trial Site
San Francisco, California, 94115, United States
Clinical Trial Site
Bradenton, Florida, 34209, United States
Clinical Trial Site
Orlando, Florida, 32803, United States
Clinical Trial Site
Chicago, Illinois, 60611, United States
Clinical Trial Site
Overland Park, Kansas, 66211, United States
Clinical Trial Site
St Louis, Missouri, 63104, United States
Clinical Trial Site
Las Vegas, Nevada, 89106, United States
Clinical Trial Site
New York, New York, 10065, United States
Clinical Trial Site
Philadelphia, Pennsylvania, 19141, United States
Clinical Trial Site
Arlington, Texas, 76012, United States
Clinical Trial Site
San Antonio, Texas, 78215, United States
Clinical Trial Site
Newport News, Virginia, 23602, United States
Clinical Trial Site
Norfolk, Virginia, 23502, United States
Clinical Trial Site
Edegem, Antwerp, 2650, Belgium
Clinical Trial Site
Haine-Saint-Paul, Hainaut, 7100, Belgium
Clinical Trial Site
Ghent, Oost-Vlaanderen, 9000, Belgium
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Alexion Pharmaceuticals Inc.
- Organization
- Alexion Pharmaceuticals Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2010
First Posted
August 12, 2010
Study Start
September 1, 2010
Primary Completion
March 1, 2012
Study Completion
April 1, 2013
Last Updated
August 30, 2023
Results First Posted
September 10, 2014
Record last verified: 2023-08