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

Primary Purpose

Hepatitis, Hepatitis C

Status

Completed

Phase

Phase 2

Locations

Russian Federation

Study Type

Interventional

Intervention

Algeron

PegIntron

Ribavirin

About this trial

This is an interventional treatment trial for Hepatitis focused on measuring Hepatitis C, Cepeginterferon alfa, Peginterferon, Treatment

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.
Documented rare hereditary diseases, such as intolerance of lactose, sucrose, fructose, lactase deficiency or glucose-galactose malabsorption.
Current alcohol or drug abuse, which in the Investigator's opinion can be contraindications for antiviral treatment or restrict treatment compliance.
Simultaneous participation in other clinical trials or prior participation in this or another clinical trial within less than 30 days after its completion.

Sites / Locations

Moscow State University of Medicine and Dentistry

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Algeron 1.5 μg/kg

Algeron 2.0 μg/kg

PegIntron

Arm Description

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).

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).

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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.

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

Full Information

NCT ID

NCT01740089

First Posted

November 30, 2012

Last Updated

July 22, 2015

Sponsor

Biocad

1. Study Identification

Unique Protocol Identification Number

NCT01740089

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Completed

Study Start Date

November 2011 (undefined)

Primary Completion Date

July 2012 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Biocad

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

After 12 weeks of treatment, an assessment of treatment efficacy was performed, i.e. rates of rapid (after 4 weeks) and early (after 12 weeks) virologic responses according to serum HCV RNA level PCR data. In patients without virologic response after 12 weeks, AVT was discontinued, and they were withdrawn from the study. Patients with EVR were enrolled in a follow-up period. During the follow-up period, patients of the first and the second group will receive Algeron in the selected therapeutic dose in combination with ribavirin, patients of the third group - PegIntron in combination with ribavirin during 12 or 36 weeks (depending on a genotype of the virus), afterwards they will be followed up without therapy for 24 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis, Hepatitis C

Keywords

Hepatitis C, Cepeginterferon alfa, Peginterferon, Treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Algeron 1.5 μg/kg

Arm Type

Experimental

Arm Description

Arm Title

Algeron 2.0 μg/kg

Arm Type

Experimental

Arm Description

Arm Title

PegIntron

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Algeron

Other Intervention Name(s)

cepeginterferon alfa-2b

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

PegIntron

Other Intervention Name(s)

Peginterferon alfa-2b

Intervention Description

1.5 μg/kg/week subcutaneously in combination with ribavirin

Intervention Type

Drug

Intervention Name(s)

Ribavirin

Intervention Description

800-1400 mg/day orally

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

Time Frame

4 weeks

Title

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.

Time Frame

24 weeks after last dose of study treatment

Title

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

Time Frame

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 Pre-specified Outcome Measures:

Title

Immunogenicity

Description

Number of randomized patients with neutralizing antibodies to IFN alfa on weeks 0, 12, 24, 48 (for patients with genotype 1 or 4) and 24 weeks after last dose of study treatment.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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. Documented rare hereditary diseases, such as intolerance of lactose, sucrose, fructose, lactase deficiency or glucose-galactose malabsorption. Current alcohol or drug abuse, which in the Investigator's opinion can be contraindications for antiviral treatment or restrict treatment compliance. Simultaneous participation in other clinical trials or prior participation in this or another clinical trial within less than 30 days after its completion.

Overall Study Officials: