CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 10 enrolled
Drug / intervention
Harvoni +1 moredrug
Likely dose
Harvoni once daily for 12 weeks (naïve or non-cirrhotic treatment-experienced) or 24 weeks (cirrhotic treatment-experienced); or Epclusa once daily for 12 weeks (naïve, non-cirrhotic, or compensated cirrhotic treatment-experienced with genotypes 1-6)AI-extracted
Key inclusion· 7
  • ✓Age ≥18 years
  • ✓HCV RNA ≥15 IU/mL at screening
  • ✓HCV genotype 1
  • ✓Chronic HCV infection documented (≥6 months)
Key exclusion· 7
  • ✕Prior exposure to approved or experimental HCV-specific DAAs (except SOF-containing regimens)
  • ✕ALT ≥10 × ULN
  • ✕AST ≥10 × ULN
  • ✕WBC ≤1500/uL

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02825212
NCT02825212Phase 3Completed
CompareCT.gov

Efficacy of All-Oral Anti-Viral Therapy for Symptomatic Hepatitis C Virus Infection-Related Cryoglobulinemia

Icahn School of Medicine at Mount Sinai·interventional·Posted Jul 7, 2016·Updated Dec 17, 2020

In Brief

A Phase 3 clinical trial evaluating Harvoni and Epclusa for Hepatitis C and Cryoglobulinemia. Completed, enrolled 10 participants across 1 site.

Detailed Summary

10 patients with chronic genotype 1 HCV infection and mixed cryoglobulinemia will be treated with Ledipasvir/Sofosbuvir 90mg/400 mg FDC once daily for 12 weeks (naïve subjects or non-cirrhotic treatment experienced subjects) or 24 weeks (treatment experienced subjects with cirrhosis). The researchers anticipate that approximately 20% of subjects may have cirrhosis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C, Cryoglobulinemia
CountriesUnited States
CollaboratorsGilead Sciences

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 7, 2016
Enrollment StartFeb 1, 2016
Primary CompletionJul 19, 2019
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 10.0 years ago

Interventions

Harvonidrug

12 weeks for naïve subjects or non-cirrhotic treatment experienced subjects; or 24 weeks for treatment experienced subjects with cirrhosis

Epclusadrug

once daily for 12 weeks (naïve subjects, non-cirrhotic treatment experienced or treatment experienced subjects with compensated cirrhosis) for genotype 1-6 subjects.