Phase 2
Completed N=12
Study of CDI-31244 in Combination With Sofosbuvir (SOF) and Velpatasvir (VEL)
Chronic Hepatitis C
Source: ClinicalTrials.gov NCT03501550 ↗
Enrolled (actual)
12
Serious AEs
16.7%
Results posted
Apr 2021
Primary outcomePrimary: Number of Subjects With Treatment Emergent Adverse Events — 10 Participants
Summary
Open label phase 2a study of two week treatment with CDI-31244 and sofosbuvir and veltapasvir followed by four week treatment of sofosbuvir and velpatasvir in individuals with chronic hepatitis C (HCV) genotype 1 (GT1) infection
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Treatment Emergent Adverse Events |
10 | — |
| PRIMARY Number of Participants With Sustained Virologic Response (SVR) 12 Weeks After Treatment |
8 | — |
| SECONDARY Number of Participants With Sustained Virologic Response (SVR) 24 Weeks After Discontinuation of Therapy |
8 | — |
Eligibility Criteria
Key Inclusion Criteria
Documented chronic HCV GT 1 infection; Serum HCV RNA >1,000 IU/mL during screening; Absence of advanced fibrosis or cirrhosis
Key Exclusion Criteria
Nursing or pregnant women; Active hepatitis B infection; Human immunodeficiency virus (HIV) infection; History of use of any HCV direct-acting antiviral therapy
Data sourced from ClinicalTrials.gov (NCT03501550). 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.