CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 23 enrolled
Drug / intervention
Harvonidrug
Likely dose
Ledipasvir 90 mg + sofosbuvir 400 mg orally once daily for 8, 12, or 24 weeksAI-extracted
Key inclusion· 4
  • ✓Age ≥18 years
  • ✓Documented PCT diagnosis with urinary total porphyrin excretion >500 mcg/g creatinine and HPLC pattern showing predominance of 8- and 7-carboxyl porphyrins
  • ✓HCV RNA positive and quantifiable in serum within 90 days of enrollment
  • ✓HCV genotypes 1, 4, 5, or 6 (Harvoni-approved genotypes)
Key exclusion· 20
  • ✕Pregnancy or breast-feeding
  • ✕Prior or current PCT treatment with phlebotomy or low-dose hydroxychloroquine/chloroquine within 30 days
  • ✕Prior or current HCV treatment within 30 days
  • ✕HIV with CD4 <350/µL or active AIDS-defining illness

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

Search/NCT03118674
NCT03118674Phase 2Completed
CompareCT.gov

Newer Direct-Acting Anti-Viral Agents as Sole Therapy of Porphyria Cutanea Tarda in Subjects With Chronic Hepatitis C

Wake Forest University Health Sciences·interventional·Posted Apr 18, 2017·Updated Jul 3, 2023

In Brief

A Phase 2 clinical trial evaluating Harvoni for Porphyria Cutanea Tarda and Hepatitis C. Completed, enrolled 23 participants across 3 sites.

Detailed Summary

In the medical literature there case reports that Harvoni improves symptoms in patients with PCT. However, this has never been systematically tested. Therefore, the purpose of this study is to assess whether Harvoni alone is an effective therapy of active PCT in patients with Chronic Hepatitis C.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPorphyria Cutanea Tarda, Hepatitis C
CountriesUnited States
CollaboratorsGilead Sciences, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedApr 18, 2017
Enrollment StartSep 6, 2017
Primary CompletionMar 4, 2022
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 9.2 years ago

Interventions

Harvonidrug

One capsule of Harvoni/ ledipasvir, 90 mg + sofosbuvir, 400 mg administered daily for 8, 12, or 24 weeks