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

Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01740089
• Other study ID #: PEG-IFN?-2
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 30, 2012
• Last updated: July 22, 2015
• Start date: November 2011
• Est. completion date: December 2013

Study information

• Verified date: July 2015
• Source: Biocad
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial 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.

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 In patients without virologic response after 12 weeks, AVT was discontinued, and they were withdrawn from the study.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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2013
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Signed informed consent to participate in the study.

2. Hepatitis ? virus infection (genotypes 1?, 1b, 2, 3, 4) confirmed by a positive quantitative PCR (HCV RNA > 50 IU/ml).

3. Males and females aged from 18 to 70 years inclusive.

4. Body mass index of 18 - 30 kg/m inclusive.

5. Increased ALT level (> 40, < 400 IU/L), documented at least twice within the last 6 months.

6. Preserved protein synthetic liver function (i.e. INR < 1.7, albumin > 35 g/l).

7. No signs of hepatic encephalopathy or abdominal fluid retention according to clinical and ultrasound examination.

8. Fertile patients and their partners agree to use barrier contraception throughout the study and 7 months after its completion.

Exclusion Criteria:

1. Intolerance of IFN alpha formulations, ribavirin or any components of these drugs according to the past medical history.

2. Infection by hepatitis B virus or HIV.

3. Past history of HCV treatment with IFN alfa or pegylated IFN alfa formulations.

4. Administration of interferons and/or interferon inducing drugs for any indication within 1 month prior to the enrollment into the study.

5. Cholestatic hepatitis (conjugated bilirubin, alkaline phosphatase, ALT levels of more than 5 ULN).

6. Decompensated liver cirrhosis confirmed by laboratory findings (Child-Pugh class B, ?) or ultrasound examination.

7. Any documented autoimmune diseases.

8. Hematologic (hemoglobin < 130 g/L for males and < 120 g/L for females; neutrophils < 1.5 ?109/L; platelets < 90 ?109/L) or biochemical abnormalities (creatinine level of more than 1.5 ULN, creatinine clearance less than 50 mL/min).

9. Documented diagnosis of hemoglobinopathies (e.g., thalassemia major, sickle-cell anemia).

10. Heavy depression, any other mental disorders, which in the Investigator's opinion can be contraindications for antiviral treatment.

11. Epilepsy and/or other functional disorders of the central nervous system.

12. Abnormal thyroid function (TTH level beyond the normal values).

13. Malignant neoplasms.

14. Pregnancy, lactation period.

15. 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.

16. Documented rare hereditary diseases, such as intolerance of lactose, sucrose, fructose, lactase deficiency or glucose-galactose malabsorption.

17. Current alcohol or drug abuse, which in the Investigator's opinion can be contraindications for antiviral treatment or restrict treatment compliance.

18. Simultaneous participation in other clinical trials or prior participation in this or another clinical trial within less than 30 days after its completion.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Algeron
1.5 µg/kg or 2.0 µg/kg of body weight weekly subcutaneously
• PegIntron
1.5 µg/kg/week subcutaneously in combination with ribavirin
• Ribavirin
800-1400 mg/day orally

Locations

Country	Name	City	State
Russian Federation	Moscow State University of Medicine and Dentistry	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Biocad

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Immunogenicity	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.	Weeks 0, 12, 24, 48 (for patients with genotype 1 or 4) and 24 weeks after last dose of study treatment	No
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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.	Yes