NCT01740089 is a Phase 2/Phase 3 clinical trial of Algeron in Hepatitis, sponsored by Biocad.

Who is sponsoring NCT01740089?

NCT01740089 is sponsored by Biocad.

What drugs are being tested in NCT01740089?

Interventions in NCT01740089: Algeron, PegIntron, Ribavirin.

What condition does NCT01740089 study?

NCT01740089 studies Hepatitis, Hepatitis C.

Is NCT01740089 still recruiting?

NCT01740089 is currently completed. Last updated 22 July 2015.

Are results published for NCT01740089?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2015-07-22 · How we verify

NCT01740089

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

Multicenter Open-label Randomized Prospective Clinical Study of Efficacy and Safety of Algeron (Cepeginterferon Alfa-2b) in Comparison With PegIntron (Peginterferon Alfa-2b) in the Combined Treatment of Chronic Hepatitis C

Completed Phase 2/Phase 3 Results posted Last updated 22 July 2015

What this trial tests

Phase 2/Phase 3 trial testing Algeron in Hepatitis in 150 participants. Completed in 1 December 2013.

Timeline

1 November 2011

Primary endpoint
1 July 2012

1 December 2013

Quick facts

Lead sponsor	Biocad
Phase	Phase 2/Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	150
Start date	1 November 2011
Primary completion	1 July 2012
Estimated completion	1 December 2013
Sites	1 location across Russia

Drugs / interventions tested

Algeron — full drug profile →
PegIntron — full drug profile →
Ribavirin — full drug profile →

Conditions studied

Hepatitis — all drugs for Hepatitis →
Hepatitis C — all drugs for Hepatitis C →

Sponsor

Biocad — full company profile →

Who can join

Adults 18 to 70, any sex, with Hepatitis or 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.

Number of Randomized Patients Achieving Early Virologic Response (EVR) - Negative PCR Result for HCV RNA (< 15 IU/ml) or ≥ 2log10 Decrease of Viral Load After 12 Weeks of Study Treatment.
Time frame: 12 weeks

Sponsor's own description

The purpose of the study is to demonstrate the noninferiority of Algeron 1.5 and 2.0 μg/kg/week in combination with ribavirin compared to PegIntron in combination with ribavirin in the treatment of chronic hepatitis C, and to determine therapeutic dose of Algeron.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Algeron

Trials testing the same drug.

NCT01889433 — An Open-label Comparative Efficacy and Safety Study of Algeron (Cepeginterferon Alfa-2b) in Treatment-naive Patients Wit · Phase 3 · completed
NCT02103439 — An Open-label Randomized Multicenter Phase III Clinical Study Comparing Safety and Efficacy of Algeron (Cepeginterferon · Phase 3 · completed

Other recruiting trials for Hepatitis

Currently open trials in the same condition.

NCT07428538 — Study to Evaluate the Safety and Efficacy of Larsucosterol in Participants With Alcohol-associated Hepatitis (AH) · Phase 3 · recruiting
NCT07442760 — ePro Diary - HDV ( MACROLIVER ) · recruiting
NCT06571981 — Conventional Ultrasound Versus Remote Ultraportable ulTrasound in the Context of Viral Hepatitis · recruiting
NCT06761261 — Acute Hepatitis in Pediatrics · recruiting

Other Biocad trials

Trials by the same sponsor.

NCT07136389 — Safety, Pharmacokinetics, Immunogenicity BCD-256-1 and Divozilimab in Subjects With Systemic Lupus Erythematosus · Phase 1 · recruiting
NCT05974969 — A Study to Assess the PK, PD, Safety and Immunogenicity of Single IV Infusion of BCD-264 and Darzalex in Healthy Subject · Phase 1 · completed
NCT05802225 — Clinical Study of the Efficacy and Safety of BCD-178 and Perjeta® as Neoadjuvant Therapy of HER2-Positive Breast Cancer · Phase 3 · active not recruiting
NCT05726630 — Clinical Study of Divozilimab in Patients With Systemic Scleroderma · Phase 3 · active not recruiting
NCT05738993 — A Double-Blind, Comparative, Randomized Clinical Study of the Pharmacokinetics, Safety, and Immunogenicity of a Single I · Phase 1 · unknown

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 NCT01740089 (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 Biocad
Last refreshed: 22 July 2015

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/NCT01740089.

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