Phase 2
N=122
Safety, Tolerability, and Antiviral Activity of ACH-0141625 or Placebo in Combination With Peginterferon and Ribavirin in Hepatitis C Virus (HCV) Positive Participants
Hepatitis C
Bottom Line
View on ClinicalTrials.gov: NCT01180790 ↗Enrolled (actual)
122
Serious AEs
8.2%
Results posted
Sep 2014
Primary outcome: Primary: Segment 1: Safety — 93.3; 100.0; 93.8; 100.0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ACH-0141625 (Sovaprevir) (Drug); Placebo (Drug); Pegylated Interferon alpha-2a (Drug); Ribavirin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alexion Pharmaceuticals, Inc.
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Segment 1: Safety |
93.3; 100.0; 93.8; 100.0; 100.0; 100.0 | — |
| PRIMARY Segment 1: Rapid Viral Response At Week 4 (RVR4) |
20.0; 75.0; 75.0; 76.5; 80.0; 25.0 | 0.003 sig |
| PRIMARY Segment 2: Safety |
94.7; 85.0; 100.0; 100.0; 95.0; 100.0 | — |
| PRIMARY Segment 2: Complete Early Virologic Response (cEVR) |
100.0; 94.0; 100.00 | 0.34 |
| SECONDARY Segment 1: cEVR |
62.5; 75.0; 70.6; 33.3 | — |
| SECONDARY Segment 2: RVR4 |
78.9; 88.8; 89.5 | — |
| SECONDARY Segment 1 And Segment 2: End Of Treatment Response |
75.0; 75.0; 64.7; 53.3; 100.0; 92.3 | — |
| SECONDARY Segment 1 And Segment 2: Sustained Virologic Response 12 Weeks (3 Months Post-dosing) (SVR12) |
56.3; 56.3; 35.3; 40.0; 80.0; 76.9 | — |
| SECONDARY Segment 1 And Segment 2: Sustained Virologic Response 24 Weeks (6 Months Post-dosing) (SVR24) |
62.5; 56.3; 35.3; 40.0; 70.0; 76.9 | — |
| SECONDARY Segment 1 And Segment 2: HCV RNA Change From Baseline |
-5.13; -4.51; -4.67; -3.48; -4.90; -5.08 | — |
| SECONDARY Segment 1 And Segment 2: HCV RNA Change From Baseline |
-5.13; -4.51; -4.67; -3.48; -4.90; -5.08 | — |
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)
Data sourced from ClinicalTrials.gov (NCT01180790). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.