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A Study to Evaluate the Safety and Efficacy of the Combined Single Dose of Dactavira Plus Or Dactavira in Egyptian Adults With Chronic Genotype 4 HCV Infection

NCT03186313 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2017-12-27

No results posted yet for this study

Summary

A phase 3 Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of the combined single dose of Dactavira Plus (EPGCG, Sofosbuvir , Daclatasvir \& Ribavirin) versus Sofosbuvir + Daclatasvir + Ribavirin (Part A) and a single dose of Dactavira (EPGCG, Sofosbuvir \& Daclatasvir) versus Sofosbuvir + Daclatasvir (Part B) in Egyptian Adults with Chronic Genotype 4 HCV Infection.

Conditions

  • Hepatitis C

Interventions

DRUG

Dactavira Plus

1 Single daily dose (2 Tablets) of Dactavira Plus each tablet contains (EPGCG 200 mg , Sofosbuvir 200mg, Daclatasvir 30 mg, Ribavirin 400 mg) for 12 weeks.

DRUG

Sofosbuvir + Daclatasvir + Ribavirin

Daily dose including Sofosbuvir 400 mg , Daclatasvir 60 mg \& Ribavirin 800 mg for 12 weeks.

DRUG

Dactavira

Single daily dose (1 Tablet) of Dactavira each tablet contains (EPGCG 400 mg , Sofosbuvir 400mg, Daclatasvir 60 mg) for 12 weeks

DRUG

Sofosbuvir + Daclatasvir

Daily dose Sofosbuvir 400 mg \& Daclatasvir 60 mg for 12 weeks

Sponsors & Collaborators

  • Wadi El Nil Hospital

    collaborator UNKNOWN

  • Egyptian Liver Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2017-05-31
Completion
2017-11-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03186313 on ClinicalTrials.gov