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
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 |
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.
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Russian Federation | Moscow State University of Medicine and Dentistry | Moscow |
Lead Sponsor | Collaborator |
---|---|
Biocad |
Russian Federation,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03686722 -
Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin
|
Phase 1 | |
Recruiting |
NCT04510246 -
Link Hepatitis C Notifications to Treatment in Tasmania
|
N/A | |
Completed |
NCT03413696 -
Effects of Health Literacy and HCV Knowledge on HCV Treatment Willingness in HIV-coinfected Patients
|
||
Completed |
NCT03109457 -
Hepatitis C Virus Detection in Oral Squamous Cell Carcinoma
|
||
Completed |
NCT03118674 -
Harvoni Treatment Porphyria Cutanea Tarda
|
Phase 2 | |
Completed |
NCT01458054 -
Effect of Omeprazole and Ritonavir on GSK2336805 Pharmacokinetics in Healthy Adults
|
Phase 1 | |
Completed |
NCT03740230 -
An Observational Study of Maviret (Glecaprevir/Pibrentasvir) for Korean Chronic Hepatitis C Genotypes 1 to 6 Patients According to the Standard for Re-examination of New Drugs
|
||
Completed |
NCT03426787 -
Helping Empower Liver and Kidney Patients
|
N/A | |
Completed |
NCT03627299 -
Renal Transplants in Hepatitis C Negative Recipients With Nucleic Acid Positive Donors
|
Phase 4 | |
Completed |
NCT00006301 -
Immune Response to Hepatitis C Virus
|
||
Active, not recruiting |
NCT03949764 -
The Kentucky Viral Hepatitis Treatment Study
|
Phase 4 | |
Completed |
NCT03365635 -
Administration of Zepatier (Grazoprevir Plus Elbasvir) in Chronic Hemodialysis (HD) Patients With Hepatitis C
|
Phase 4 | |
Recruiting |
NCT04405024 -
Pilot Study on the Feasibility of Systematic Hepatitis C Screening of Hospitalized Patients
|
N/A | |
Completed |
NCT04525690 -
Improving Inpatient Screening for Hepatitis C
|
N/A | |
Completed |
NCT04033887 -
Evaluation Study of RDTs Detecting Antibodies Against HCV
|
||
Withdrawn |
NCT04546802 -
HepATocellular Cancer Hcv Therapy Study
|
Phase 3 | |
Active, not recruiting |
NCT02961426 -
Strategic Transformation of the Market of HCV Treatments
|
Phase 2/Phase 3 | |
Completed |
NCT02705534 -
Sofosbuvir, Ledipasvir, Ribavirin for Hepatitis C Cirrhotics, Genotype 1
|
Phase 3 | |
Completed |
NCT02992184 -
PoC-HCV Genedrive Viral Detection Assay Validation Study
|
N/A | |
Completed |
NCT02683005 -
Study of Hepatitis C Treatment During Pregnancy
|
Phase 1 |