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Trial record 79 of 535 for:    IFNA2 AND RBV AND HCV

Vitamin D and Vitamin B12 Supplementation With Pegylated Interferon-Alfa Plus Ribavirin for Treating Chronic Hepatitis C

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ClinicalTrials.gov Identifier: NCT02120274
Recruitment Status : Terminated (New Brazilian Guidelines for Viral Hepatitis C and Coinfetions. It does not include the treatment of chronic HCV Metavir < F3 and abandon the use of interferon.)
First Posted : April 22, 2014
Last Update Posted : August 24, 2016
Sponsor:
Information provided by (Responsible Party):
Henrique Pott Junior, Federal University of São Paulo

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
RNA Virus Infections Flaviviridae Infections Hepatitis C Hepatitis C, Chronic Drug: Vitamin D Drug: Vitamin B 12 Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Start Date : March 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016


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.
Drug: Vitamin D
Oral vitamin D 2,000 IU qd throughout, irrespective of baseline vitamin D level.

Drug: Vitamin B 12
Intramuscular vitamin B12 5000 UI will be given weekly in the first 12 weeks followed by a monthly injection until the end of therapy.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. RVR, EVR, EOT [ Time Frame: week 4, week 12 and at the end-of-treatment. ]
    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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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02120274


Locations
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Brazil
Outpatient Clinic of Viral Hepatitis (NUPAIG)
São Paulo, Brazil, 04025-001
Sponsors and Collaborators
Federal University of São Paulo
Investigators
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Study Director: Adauto Castelo, PhD Federal University of São Paulo
Study Chair: Jorge F Senise, PhD Federal University of São Paulo

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Responsible Party: Henrique Pott Junior, Dr. Henrique Pott-Junior, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT02120274     History of Changes
Other Study ID Numbers: DB12SHCV
U1111-1155-6986 ( Other Identifier: Universal Trial Number )
First Posted: April 22, 2014    Key Record Dates
Last Update Posted: August 24, 2016
Last Verified: August 2016
Keywords provided by Henrique Pott Junior, Federal University of São Paulo:
RNA Virus Infections
Flaviviridae Infections
Hepatitis C
Hepatitis C, Chronic
Vitamin D
Cholecalciferol
Vitamin B 12
Additional relevant MeSH terms:
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Hepatitis C
Hepatitis C, Chronic
Ribavirin
Interferon-alpha
Infection
Communicable Diseases
Hepatitis A
RNA Virus Infections
Flaviviridae Infections
Hepatitis
Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Hepatitis, Chronic
Vitamin D
Ergocalciferols
Vitamins
Hydroxocobalamin
Vitamin B 12
Vitamin B Complex
Interferons
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents