Who is sponsoring NCT02309450?

NCT02309450 is sponsored by ANRS, Emerging Infectious Diseases.

What drugs are being tested in NCT02309450?

Interventions in NCT02309450: .Asunaprevir, Daclatasvir and BMS - 791325.

What condition does NCT02309450 study?

NCT02309450 studies Hepatitis C Virus Genotype 4 Infection.

Is NCT02309450 still recruiting?

NCT02309450 is currently withdrawn. Last updated 1 February 2016.

Last reviewed 2016-02-01 · How we verify

NCT02309450: QUATTROTURBO

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Pilot Study to Assess Efficacy and Safety of a Triple Therapy With Asunaprevir, Daclatasvir and BMS-791325 in HCV Genotype 4-infected Patients After Failure of Pegylated Interferon-Ribavirin Regimen

Withdrawn Phase 2 Last updated 1 February 2016

What this trial tests

Phase 2 trial testing .Asunaprevir, Daclatasvir and BMS - 791325 in Hepatitis C Virus Genotype 4 Infection. Withdrawn.

Timeline

1 December 2014

Primary endpoint
1 November 2015

1 August 2016

Quick facts

Lead sponsor	ANRS, Emerging Infectious Diseases
Phase	Phase 2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Start date	1 December 2014
Primary completion	1 November 2015
Estimated completion	1 August 2016
Sites	1 location across France

Drugs / interventions tested

.Asunaprevir, Daclatasvir and BMS - 791325 — full drug profile →

Conditions studied

Hepatitis C Virus Genotype 4 Infection — all drugs for Hepatitis C Virus Genotype 4 Infection →

Sponsor

ANRS, Emerging Infectious Diseases — full company profile →

Who can join

18 and older, any sex, with Hepatitis C Virus Genotype 4 Infection. 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.

HCV sustained virological response rate
Time frame: week 24
The primary endpoint is the Sustained Virological Response Rate defined by an undetectable HCV RNA at W24, that is to say 12 weeks after the end of the DCV 3DAA therapy associating Asunaprevir, Daclatasvir and BMS - 791325 (SVR12). In case of premature total or partial interruption of HCV treatment, the primary endpoint will also be assessed at week 24.

Sponsor's own description

ANRS HC 33 is a pilot study to assess efficacy and safety of a DCV 3DAA therapy with Asunaprevir, Daclatasvir and BMS-791325 in HCV genotype 4-infected patients after failure of pegylated Interferon-Ribavirin regimen. Proportion of patients with cirrhosis will be limited to 50% of all patients included, cirrhosis being defined as a METAVIR score of F4 on the liver biopsy or an hepatic impulse elastometry ≥ 14 kPa or a Fibrotest® result \> 0,75.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other ANRS, Emerging Infectious Diseases trials

Trials by the same sponsor.

NCT07098481 — Access to Hepatitis C Treatment in Cameroon: Comparison of a Simplified Test and Treat Strategy to a Standard Strategy · Phase 4 · not yet recruiting
NCT06913959 — HIV-1 Non-group M in Cameroon : Study of Genotypic and Phylogenetic Diversity (OBSOCAM) · not yet recruiting
NCT07113106 — Dose Escalation Trial of CD40.Pan.CoV Vaccine, Adjuvanted or Not, as a Booster in Adult Healthy Volunteers · Phase 1, PHASE2 · recruiting
NCT05222945 — A Study to Determine the Cartography of Virologic Reservoir Related to Antiretroviral Concentrations in HIV-1 Chronic Pa · NA · not yet recruiting
NCT06522256 — Identification of Molecular Signatures of High-risk Oncogenic HPV and Study of Their Associations With the Presence of H · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02309450 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by ANRS, Emerging Infectious Diseases
Last refreshed: 1 February 2016

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02309450.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing