# An Efficacy, Safety, Tolerability and Pharmacokinetics Study of 12 Weeks Treatment With Simeprevir and Daclatasvir in Participants With Chronic Hepatitis C Virus Genotype 1b or 4 Infection and Either Severe Renal Impairment or End-stage Renal Disease on Hemodialysis.

> **NCT02397395** · PHASE2 · WITHDRAWN · sponsor: **Janssen R&D Ireland**

## Conditions studied

- Renal Impairment
- End-stage Renal Disease

## Interventions

- **DRUG:** Simeprevir (SMV) 150 mg
- **DRUG:** Daclatasvir (DCV) 60 mg

## Key facts

- **NCT ID:** NCT02397395
- **Lead sponsor:** Janssen R&D Ireland
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** WITHDRAWN
- **Start date:** 2015-05
- **Primary completion:** 2016-02
- **Final completion:** 2016-05
- **Target enrollment:** 0 (ACTUAL)
- **Why stopped:** Trial has been cancelled due to availability of new therapeutic options for patient population
- **Last updated:** 2015-07-17


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT02397395

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT02397395, "An Efficacy, Safety, Tolerability and Pharmacokinetics Study of 12 Weeks Treatment With Simeprevir and Daclatasvir in Participants With Chronic Hepatitis C Virus Genotype 1b or 4 Infection and Either Severe Renal Impairment or End-stage Renal Disease on Hemodialysis.". Retrieved via AI Analytics 2026-07-02 from https://api.ai-analytics.org/clinical/NCT02397395. Licensed CC0.

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