- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02120274
Vitamin D and Vitamin B12 Supplementation With Pegylated Interferon-Alfa Plus Ribavirin for Treating Chronic Hepatitis C
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Randomized clinical trial comparing rates of RVR, eRVR, EOT and SVR during standard treatment with Pegylated Interferon-Alfa plus Ribavirin compared to the same treatment supplemented with B12 and vitamin D during the treatment period.
Patients assigned to the vitamin supplementation group will receive the standard treatment of Pegylated Interferon-Alfa plus Ribavirin for 48 weeks together oral Vitamin D and intramuscular Vitamin B12. The control group will receive the same regimen of peguilated alfainterferon plus ribavirin for 48 weeks without any vitamin supplementation.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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-
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São Paulo, Brazil, 04025-001
- Outpatient Clinic of Viral Hepatitis (NUPAIG)
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
Pegylated Interferon-Alfa plus ribavirin for 48 weeks
|
|
Experimental: Vitamins
Pegylated Interferon-Alfa plus ribavirin for 48 weeks together oral vitamin D 2,000 IU qd throughout, irrespective of baseline vitamin D level.
Intramuscular vitamin B12 5000 UI will be given weekly in the first 12 weeks followed by a monthly injection until the end of therapy.
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Oral vitamin D 2,000 IU qd throughout, irrespective of baseline vitamin D level.
Intramuscular vitamin B12 5000 UI will be given weekly in the first 12 weeks followed by a monthly injection until the end of therapy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SVR12
Time Frame: 12 weeks after treatment completion
|
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.
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12 weeks after treatment completion
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
RVR, EVR, EOT
Time Frame: week 4, week 12 and at the end-of-treatment.
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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);
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week 4, week 12 and at the end-of-treatment.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Adauto Castelo, PhD, Federal University of São Paulo
- Study Chair: Jorge F Senise, PhD, Federal University of São Paulo
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Blood-Borne Infections
- Disease Attributes
- Liver Diseases
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis, Chronic
- Infections
- Communicable Diseases
- Hepatitis
- Hepatitis A
- Hepatitis C
- Virus Diseases
- Hepatitis C, Chronic
- RNA Virus Infections
- Flaviviridae Infections
- Physiological Effects of Drugs
- Micronutrients
- Bone Density Conservation Agents
- Vitamin B Complex
- Hematinics
- Vitamin D
- Vitamins
- Vitamin B 12
- Hydroxocobalamin
Other Study ID Numbers
- DB12SHCV
- U1111-1155-6986 (Other Identifier: Universal Trial Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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