Phase 2
Completed N=151
Study in Genotype 2 or 3 Patients With Chronic Hepatitis Virus Infection
Source: ClinicalTrials.gov NCT01257204 ↗Enrolled (actual)
151
Serious AEs
3.0%
Results posted
Dec 2015
Primary outcomePrimary: Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 24 (SVR24) for Hepatitis C Virus (HCV) Genotype 2 — 83.3; 82.6; 62.5 percentage of participants
Summary
To identify a shorter duration of antiviral therapy (12 or 16 weeks) for the combination of daclatasvir with pegylated interferon alfa-2a and ribavirin.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 24 (SVR24) for Hepatitis C Virus (HCV) Genotype 2 |
83.3; 82.6; 62.5 | — |
| PRIMARY Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 24 (SVR24) for Hepatitis C Virus (HCV) Genotype 3 |
69.2; 66.7; 59.3 | — |
| SECONDARY Percentage of Participants Achieving Rapid Virologic Response (RVR) at Week 4 for Hepatitis C Virus (HCV) Genotype 2 |
87.5; 73.9; 41.7 | — |
| SECONDARY Percentage of Participants Achieving Rapid Virologic Response (RVR) at Week 4 for Hepatitis C Virus (HCV) Genotype 3 |
84.6; 74.1; 37.0 | — |
| SECONDARY Percentage of Participants Achieving Complete Early Virologic Response (cEVR) at Week 12 for Hepatitis C Virus (HCV) Genotype 2 |
91.7; 82.6; 75.0 | — |
| SECONDARY Percentage of Participants Achieving Complete Early Virologic Response (cEVR) at Week 12 for Hepatitis C Virus (HCV) Genotype 3 |
80.8; 88.9; 59.3 | — |
| SECONDARY Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 12 (SVR12) for Hepatitis C Virus (HCV) Genotype 2 |
87.5; 82.6; 70.8 | — |
| SECONDARY Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 12 (SVR12) for Hepatitis C Virus (HCV) Genotype 3 |
69.2; 77.8; 51.9 | — |
| SECONDARY Number of Participants With Virologic Failure for Hepatitis C Virus (HCV) Genotype 2 |
0; 1; 1; 0; 1; 0 | — |
| SECONDARY Number of Participants With Virologic Failure for Hepatitis C Virus (HCV) Genotype 3 |
0; 0; 1; 0; 1; 3 | — |
| SECONDARY Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Treatment-related AEs and Who Died During Treatment Period |
49; 49; 50; 4; 0; 3 | — |
| SECONDARY Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Who Died During Follow-up Period |
16; 12; 11; 2; 0; 0 | — |
Eligibility Criteria
Key Inclusion Criteria
- Participants chronically infected with hepatitis C virus (HCV) genotype 2 or 3
- No previous exposure to an interferon formulation (ie, interferon alfa, pegylated interferon alfa-2a ) or ribavirin
- Body mass index (BMI) of 18 to 35 kg/m^2, inclusive. BMI=weight (kg)/height (m)^2
- Males and females, 18 - 70 years of age
Key Exclusion Criteria
- Liver transplant recipients
- Documented or suspected hepatocellular carcinoma
- Evidence of decompensated cirrhosis
- History of chronic hepatitis B virus (HBV). Patients with resolved HBV infection may participate
- Current or known history of cancer
- Any gastrointestinal disease or surgical procedure that may impact the absorption of study drug
- Inability to tolerate oral medication
- Poor venous access
- Severe psychiatric disease
- History of chronic pulmonary disease
- History of cardiomyopathy, coronary artery disease (including angina), interventive procedure for coronary artery disease (including angioplasty, stent procedure, or cardiac bypass surgery), ventricular arrhythmia,, or other clinically significant cardiac disease
- History of or current electrocardiogram findings indicative of cardiovascular instability
- Preexisting ophthalmologic disorders considered clinically significant on eye
- History of uncontrolled diabetes mellitus
- Any known contraindication to pegylated interferon alfa-2a or ribavirin not otherwise specified.
- Positive hepatitis B virus surface antigen, HIV-1 or HIV-2 Ab
- Prior exposure to any HCV direct antiviral agent (eg, HCV protease, polymerase, previous nonstructural protein 5A inhibitors)
- Exposure to any investigational drug or placebo
Data sourced from ClinicalTrials.gov (NCT01257204). 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. Informational only — not medical advice.