Vitamin D + Telaprevir + Peginterferon + Ribavirin for of Hepatitis C Genotype 1
A Pilot Trial of the Safety and Efficacy of Telaprevir +Peginterferon +Ribavirin +Vitamin D3 Among Treatment-naive Veterans Infected With Genotype 1 Hepatitis C Virus
1 other identifier
interventional
N/A
1 country
4
Brief Summary
This study is for people who have been diagnosed with chronic hepatitis C, specifically those who have a certain type of the virus, genotype 1, and who have not yet received treatment for hepatitis C. This pilot study is designed to test whether the addition of vitamin D, to the three drugs (Incivek (telaprevir), Pegasys (peginterferon alfa-2a), and ribavirin) that are approved by the Food and Drug Administration (FDA) for the treatment of hepatitis C, can help eliminate the HCV from the body. Currently, doctors are unsure if the addition of vitamin D to prescribed hepatitis C therapy will have any effects on how the body clears the virus. Once enrolled, participants will be randomly assigned (like flipping a coin) to receive telaprevir + peginterferon alfa-2a + ribavirin + vitamin D3 (treatment group) or telaprevir + peginterferon alfa-2a + ribavirin (control group). A total of 80 participants, of all races/ethnicities, will be included in this study, at 5 to 10 VA hospital study sites (10 - 20 participants/site). Participants assigned to the treatment group will begin a lead-in phase where they will receive 5,000 IU of vitamin D3 per day. Every two weeks during the lead-in phase, participants will be tested to determine the Vitamin D level in their blood, as well as other tests, including HCV RNA (to determine the amount of virus present) and calcium levels. Once an adequate level of Vitamin D is detected in participants' blood, participants will begin treatment with telaprevir + peginterferon alfa-2a + ribavirin + vitamin D3 (15,000 IU/week) for 12 weeks. Participants randomized to the control group will immediately begin treatment with telaprevir + peginterferon alfa-2a + ribavirin for 12 weeks. At the end of Week 12 the participants' involvement in the study will be complete. Adverse events and effects of vitamin D3 will be obtained by assessing participants' medical history, physical examination, and blood tests at clinic visits. HCV RNA will be assessed at Screening, Day 1, Week 2, 4, 8 and 12.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 31, 2013
CompletedFirst Posted
Study publicly available on registry
July 2, 2013
CompletedStudy Start
First participant enrolled
August 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedMay 14, 2014
May 1, 2014
2.2 years
May 31, 2013
May 13, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HCV RNA
Hepatitis C virus Ribonucleic Acid identifies the presence of Hepatitis C in the blood
4 weeks
Secondary Outcomes (1)
adverse event profile
12 weeks
Study Arms (2)
VitD+telaprevir+peginterferon+ribavirin
ACTIVE COMPARATORParticipants randomized to the treatment group will receive 5,000IU/day of vitamin D3 during the lead-in phase. When the serum 25(OH)D level is ≥35ng/ml the participant will begin telaprevir + vitamin D3 (15,000IU/week) + peginterferon alfa-2a (180ug/week) + weight based ribavirin treatment.
Telaprevir + Peginterferon + Ribavirin
ACTIVE COMPARATORParticipants randomized to the control group immediately begin treatment with telaprevir + 180ug of peginterferon alfa-2a (Pegasys) per week and either weight based ribavirin.
Interventions
Eligibility Criteria
You may qualify if:
- Chronic Hepatitis C genotype 1 infection
- Treatment naïve
- Age \>18 years
- Agree to genetic testing
You may not qualify if:
- Liver disease other than from hepatitis C
- HCV infection with mixed genotypes
- Decompensated liver disease
- AFP\>100ng/ml.
- Known HIV infection
- Serum 25(OH)D less than 12ng/ml or greater than 30ng/ml
- Regular vitamin D supplement use
- Regular calcium supplement use
- Refusal to abstain from vitamin D supplementation
- Current or past history of kidney stones
- Current use of any of the prohibited medications listed in section 5.5 and the INCIVEK® package insert.
- Need for therapeutic vitamin D or calcium (e.g. treatment for osteoporosis, osteomalacia, hyperparathyroidism etc.), in the opinion of the investigator
- Significant substance abuse within the past 6 months,
- Suicidal attempt in the past 10 years or suicidal ideation in past 3 months, or any other psychiatric condition that the investigator deems would make a subject unsuited for treatment with peginterferon or ribavirin.
- Confirmed or suspected malignancy, or history of malignancy within the past 3 years (except treated basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix)
- +18 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Timothy Morgan, MDlead
- Vertex Pharmaceuticals Incorporatedcollaborator
Study Sites (4)
VA Long Beach Healthcare System
Long Beach, California, 90822, United States
Minneapolis VAHCS
Minneapolis, Minnesota, 55417, United States
Kansas City VA Medical Center
Kansas City, Missouri, 64128, United States
Philadelphia VA Medical Center
Philadelphia, Pennsylvania, 19104, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Timothy R Morgan, MD
Veterans Affairs Long Beach Healthcare
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Chief, Hepatology
Study Record Dates
First Submitted
May 31, 2013
First Posted
July 2, 2013
Study Start
August 1, 2013
Primary Completion
October 1, 2015
Last Updated
May 14, 2014
Record last verified: 2014-05