Hepatitis C Clinical Trial
Official title:
Randomized Clinical Trial to Assess the Effectiveness of Vitamin D and Vitamin B12 Supplementation in Combination With Pegylated Interferon-Alfa Plus Ribavirin for Treating Chronic Hepatitis C.
Verified date | August 2016 |
Source | Federal University of São Paulo |
Contact | n/a |
Is FDA regulated | No |
Health authority | Brazil: Ethics Committee |
Study type | Interventional |
The purpose of this study is to evaluate the effectiveness of the supplementation of vitamins D and B12 in combination with Pegylated Interferon-Alfa and Ribavirin in the treatment of genotype 1 chronic hepatitis C, who do not qualify to receive protease inhibitor in Brazil.
Status | Terminated |
Enrollment | 85 |
Est. completion date | May 2016 |
Est. primary completion date | May 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Genotype 1 HCV infection confirmed a positive test for anti-HCV antibody and detectable serum HCV RNA by PCR - Pegylated Interferon-Alfa treatment naïve - Liver biopsy with Metavir F2 or less - Cognitive capacity to understand and sign the informed consent Exclusion Criteria: - HBV or HIV co-infection - Hemoglobin level less than 10 g/dL or total neutrophil count less than 1,500/mm3 or platlet count below 75,000/mm3 - Creatinin = 1.5 mg/dL - Severe cardiopathy - Pregnancy or impossibility to use birth control methods by the couple, or breast-feeding - Conditions that, according to the investigator's judgement, preclude participation in the study, including clinical, cognitive or behavioural conditions |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Outpatient Clinic of Viral Hepatitis (NUPAIG) | São Paulo |
Lead Sponsor | Collaborator |
---|---|
Federal University of São Paulo |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | SVR12 | Proportion of patients with SVR, defined as HCV RNA bellow the limit of detection 12 weeks after treatment completion with peguilated alfainterferon-2B plus ribavirin, with or without vitamin supplementation. | 12 weeks after treatment completion | No |
Secondary | RVR, EVR, EOT | Proportion of patients presenting HCV RNA bellow the limit of detection at week 4 (RVR), week 12 (EVR - early virological response) and at the end-of-treatment (EOT); | week 4, week 12 and at the end-of-treatment. | No |
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 |
NCT03118674 -
Harvoni Treatment Porphyria Cutanea Tarda
|
Phase 2 | |
Completed |
NCT03109457 -
Hepatitis C Virus Detection in Oral Squamous Cell Carcinoma
|
||
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 |
NCT02869776 -
Integrating HCV and HIV Screening During the Era of HIV Antigen Testing
|
N/A | |
Completed |
NCT02705534 -
Sofosbuvir, Ledipasvir, Ribavirin for Hepatitis C Cirrhotics, Genotype 1
|
Phase 3 | |
Completed |
NCT03186313 -
A Study to Evaluate the Safety and Efficacy of the Combined Single Dose of Dactavira Plus Or Dactavira in Egyptian Adults With Chronic Genotype 4 HCV Infection
|
Phase 3 |