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Vitamin D + Telaprevir + Peginterferon + Ribavirin for of Hepatitis C Genotype 1

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ClinicalTrials.gov Identifier: NCT01890772
Recruitment Status : Withdrawn
First Posted : July 2, 2013
Last Update Posted : May 14, 2014
Sponsor:
Collaborator:
Vertex Pharmaceuticals Incorporated
Information provided by (Responsible Party):
Timothy Morgan, MD, Southern California Institute for Research and Education

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.


Condition or disease Intervention/treatment Phase
Hepatitis C Drug: Telaprevir Drug: Peginterferon alfa-2a Drug: Ribavirin Dietary Supplement: Vitamin D Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2013
Estimated Primary Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: VitD+telaprevir+peginterferon+ribavirin
Participants 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.
Drug: Telaprevir
Other Name: Incivek

Drug: Peginterferon alfa-2a
Other Name: Pegasys

Drug: Ribavirin
Dietary Supplement: Vitamin D
Active Comparator: Telaprevir + Peginterferon + Ribavirin
Participants randomized to the control group immediately begin treatment with telaprevir + 180ug of peginterferon alfa-2a (Pegasys) per week and either weight based ribavirin.
Drug: Telaprevir
Other Name: Incivek

Drug: Peginterferon alfa-2a
Other Name: Pegasys

Drug: Ribavirin



Primary Outcome Measures :
  1. HCV RNA [ Time Frame: 4 weeks ]
    Hepatitis C virus Ribonucleic Acid identifies the presence of Hepatitis C in the blood


Secondary Outcome Measures :
  1. adverse event profile [ Time Frame: 12 weeks ]
    Cumulative record of unanticipated or unintended medical occurrences, not necessarily related to the study treatment.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic Hepatitis C genotype 1 infection
  • Treatment naïve
  • Age >18 years
  • Agree to genetic testing

Exclusion Criteria:

  • 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)
  • Any autoimmune disease not easily controlled (in the opinion of the investigator)
  • Any condition resulting in malabsorption (
  • Poorly controlled thyroid disorder, or diabetes mellitus (HbA1c > 9)
  • Glomerular diseases (e.g., glomerulosclerosis or glomerulonephritis) associated with a serum creatinine >1.5 times the upper limit of normal
  • Current or history of any clinically significant cardiac abnormalities/dysfunction (eg, angina, congestive heart failure, myocardial infarction, pulmonary hypertension, complex congenital heart disease, cardiomyopathy, significant arrhythmia) including current uncontrolled hypertension or history of use of antianginal agents for cardiac conditions (Inclusion will be considered if clearance by a cardiologist is obtained.)
  • Receipt of an investigational drug within the past 30 days
  • Females who have a positive pregnancy test at the time of screening, are breastfeeding or who anticipate pregnancy within the next 18 months, or men with pregnant partners
  • Lack of agreement from subject to use two forms of acceptable contraception
  • History or other evidence of any significant illness which, in the opinion of the investigator, would make the patient, unsuitable for the study
  • Laboratory Exclusions

Hemoglobin: <12gm/dl male or female

Neutrophil: <1,200/mm3

Platelets: <90,000/mm3

INR: >1.5

Albumin: <3.2gm/dl

Total Bilirubin: >2.0mg/dl

HbA1c: >9.5%

Serum Creatinine: >1.5 times the upper limit of normal

Serum Calcium Within local laboratory normal range

Parathyroid hormone (PTH) <10 or >55 pg/mL


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): NCT01890772


Locations
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United States, California
VA Long Beach Healthcare System
Long Beach, California, United States, 90822
United States, Minnesota
Minneapolis VAHCS
Minneapolis, Minnesota, United States, 55417
United States, Missouri
Kansas City VA Medical Center
Kansas City, Missouri, United States, 64128
United States, Pennsylvania
Philadelphia VA Medical Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Timothy Morgan, MD
Vertex Pharmaceuticals Incorporated
Investigators
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Principal Investigator: Timothy R Morgan, MD Veterans Affairs Long Beach Healthcare

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Responsible Party: Timothy Morgan, MD, Chief, Hepatology, Southern California Institute for Research and Education
ClinicalTrials.gov Identifier: NCT01890772     History of Changes
Other Study ID Numbers: 1217
First Posted: July 2, 2013    Key Record Dates
Last Update Posted: May 14, 2014
Last Verified: May 2014

Keywords provided by Timothy Morgan, MD, Southern California Institute for Research and Education:
Hepatitis C Genotype 1
Vitamin D
treatment-naive

Additional relevant MeSH terms:
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Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunologic Factors