NCT02371408

A Phase IIb/IIIa, Randomized Study to Evaluate the Efficacy and Safety of PPI-668 (NS5A Inhibitor) Plus Sofosbuvir, With or Without Ribavirin, in Patients With Chronic Hepatitis C Genotype-4

Status unknown Phase 2/Phase 3 Last updated 6 April 2016

What this trial tests

Phase 2/Phase 3 trial testing ravidasvir hydrochloride in Chronic Hepatitis C in 300 participants. Status unknown.

Timeline

1 January 2015

Primary endpoint
1 January 2016

1 April 2016

Quick facts

Lead sponsor	Pharco Pharmaceuticals
Phase	Phase 2/Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	300
Start date	1 January 2015
Primary completion	1 January 2016
Estimated completion	1 April 2016
Sites	3 locations across Egypt

Drugs / interventions tested

• ravidasvir hydrochloride — full drug profile →
• sofosbuvir — full drug profile →
• ribavirin — full drug profile →

Conditions studied

• Chronic Hepatitis C — all drugs for Chronic Hepatitis C →

Sponsor

Pharco Pharmaceuticals

Who can join

Adults 18 to 65, any sex, with Chronic Hepatitis C. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Proportions of patients who achieve Sustained Virologic Response at 12 weeks post-treatment (SVR12)
  Time frame: post-treatment week 12
  Sustained Virologic Response is defined as serum HCV RNA \< LLOQ at post-treatment visits.

Sponsor's own description

The study will assess the efficacy of PPI-668 (USAN: ravidasvir hydrochloride) in combination with sofosbuvir, with or without ribavirin, in the following Egyptian HCV gt-4 patient populations:

1. Treatment-naïve patients, with and without cirrhosis (Group 1)
2. Previous non-responders to interferon-based therapies, without cirrhosis (Group 2)
3. Previous non-responders to interferon-based therapies, with cirrhosis (Group 3)

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Current therapy for chronic hepatitis C: The role of direct-acting antivirals.
   Li G, De Clercq E. · · 2017 · cited 111× · PMID 28238877 · DOI 10.1016/j.antiviral.2017.02.014
2. Effectiveness of ravidasvir plus sofosbuvir in interferon-naïve and treated patients with chronic hepatitis C genotype-4.
   Esmat G, Elbaz T, El Raziky M, Gomaa A, et al · · 2017 · cited 11× · PMID 28935432 · DOI 10.1016/j.jhep.2017.09.006