Algeron (Cepeginterferon Alfa-2b) Compared With PegIntron (Peginterferon Alfa-2b) for Treatment of Chronic Hepatitis C

NCT01740089 | Completed Phase 2 Results

• 1 other identifier: PEG-IFNа-2
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatitis; Hepatitis C

Keywords

Hepatitis C; Cepeginterferon alfa; Peginterferon; Treatment

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (3)

• Number of Randomized Patients Achieving Rapid Virologic Response (RVR) - Negative PCR Result for HCV RNA (< 15 IU/ml) After 4 Weeks of Treatment.

  4 weeks

• Number of Randomized Patients Achieving Sustained Virologic Response (SVR) - Negative PCR Result for HCV RNA (< 15 IU/ml) 24 Weeks After Last Dose of Study Treatment.

  24 weeks after last dose of study treatment

• Number of Patients Who Have Undetectable HCV RNA (< 15 IU/ml) at the End of Treatment.

  After 24 weeks of treatment for patients with genotype 2 or 3 and after 48 weeks of treatment for patients with genotype 1 or 4.

Other Outcomes (1)

• Immunogenicity

  Weeks 0, 12, 24, 48 (for patients with genotype 1 or 4) and 24 weeks after last dose of study treatment

Study Arms (3)

Algeron 1.5 μg/kg

EXPERIMENTAL

Algeron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight \< 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight \> 105 kg).

Drug: Algeron; Drug: Ribavirin

Algeron 2.0 μg/kg

EXPERIMENTAL

Algeron 2.0 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight \< 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight \> 105 kg).

Drug: Algeron; Drug: Ribavirin

PegIntron

ACTIVE COMPARATOR

PegIntron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight \< 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight \> 105 kg).

Drug: PegIntron; Drug: Ribavirin

Interventions

Algeron DRUG

1.5 μg/kg or 2.0 μg/kg of body weight weekly subcutaneously

Also known as: cepeginterferon alfa-2b

Algeron 1.5 μg/kg; Algeron 2.0 μg/kg

PegIntron DRUG

1.5 μg/kg/week subcutaneously in combination with ribavirin

Also known as: Peginterferon alfa-2b

PegIntron

Ribavirin DRUG

800-1400 mg/day orally

Algeron 1.5 μg/kg; Algeron 2.0 μg/kg; PegIntron

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent to participate in the study.
• Hepatitis С virus infection (genotypes 1а, 1b, 2, 3, 4) confirmed by a positive quantitative PCR (HCV RNA \> 50 IU/ml).
• Males and females aged from 18 to 70 years inclusive.
• Body mass index of 18 - 30 kg/m inclusive.
• Increased ALT level (\> 40, \< 400 IU/L), documented at least twice within the last 6 months.
• Preserved protein synthetic liver function (i.e. INR \< 1.7, albumin \> 35 g/l).
• No signs of hepatic encephalopathy or abdominal fluid retention according to clinical and ultrasound examination.
• Fertile patients and their partners agree to use barrier contraception throughout the study and 7 months after its completion.

You may not qualify if:

• Intolerance of IFN alpha formulations, ribavirin or any components of these drugs according to the past medical history.
• Infection by hepatitis B virus or HIV.
• Past history of HCV treatment with IFN alfa or pegylated IFN alfa formulations.
• Administration of interferons and/or interferon inducing drugs for any indication within 1 month prior to the enrollment into the study.
• Cholestatic hepatitis (conjugated bilirubin, alkaline phosphatase, ALT levels of more than 5 ULN).
• Decompensated liver cirrhosis confirmed by laboratory findings (Child-Pugh class B, С) or ultrasound examination.
• Any documented autoimmune diseases.
• Hematologic (hemoglobin \< 130 g/L for males and \< 120 g/L for females; neutrophils \< 1.5 х109/L; platelets \< 90 х109/L) or biochemical abnormalities (creatinine level of more than 1.5 ULN, creatinine clearance less than 50 mL/min).
• Documented diagnosis of hemoglobinopathies (e.g., thalassemia major, sickle-cell anemia).
• Heavy depression, any other mental disorders, which in the Investigator's opinion can be contraindications for antiviral treatment.
• Epilepsy and/or other functional disorders of the central nervous system.
• Abnormal thyroid function (TTH level beyond the normal values).
• Malignant neoplasms.
• Pregnancy, lactation period.
• Severe comorbidities (for example, severe hypertension, severe coronary heart disease, decompensated diabetes mellitus), which in the Investigator's opinion can be contraindications for antiviral treatment.

Sponsors & Collaborators

• Biocad: lead

Study Sites (1)

Moscow State University of Medicine and Dentistry

Moscow, 127473, Russia

Location

MeSH Terms

Conditions

Hepatitis; Hepatitis C

Interventions

peginterferon alfa-2b; Ribavirin

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Yulia Linkova Medical Director
• Organization: Biocad

linkova@biocad.ru

+7 (495) 992 66 28

Study Officials

• Olga Znoyko, professor

  Moscow State University of Medicine and Dentistry

  PRINCIPAL INVESTIGATOR

• Marina Maevskaya, professor

  The First Moscow State Sechenov Medical University

  PRINCIPAL INVESTIGATOR

• Svetlana Kizhlo

  Health Department "Center for Prevention and Control of AIDS and Infectious Diseases"

  PRINCIPAL INVESTIGATOR

• Natalia Petrochenkova

  Smolensk State Medical Academy

  PRINCIPAL INVESTIGATOR

• Semen Maximov

  Moscow State University of Medicine and Dentistry

  PRINCIPAL INVESTIGATOR

• Firaja Nagimova

  Kazan State Medical University

  PRINCIPAL INVESTIGATOR

• Vladimur Yakovlev

  7. St. Petersburg State Institution of Health "Clinical Infectious Diseases Hospital named SP Botkin"

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2012
• First Posted: December 4, 2012
• Study Start: November 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: December 1, 2013
• Last Updated: August 18, 2015
• Results First Posted: August 18, 2015

Record last verified: 2015-07

Locations

RU (1)