Hepatitis CPhase 2/3NCT01890772
Vitamin D + Telaprevir + Peginterferon + Ribavirin for of Hepatitis C Genotype 1
A Phase 2/3 study testing Telaprevir, Peginterferon alfa-2a and Ribavirin in people with Hepatitis C, run by Timothy Morgan, MD at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Telaprevir, Peginterferon alfa-2a and Ribavirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 4 sitesUnited States
- Study dates
- Aug 2013to Oct 2015
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic Hepatitis C genotype 1 infection
- Treatment naïve
- Age >18 years
- Agree to genetic testing
Who cannot join
- 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
Show all 35Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Kansas City VA Medical Center
Kansas City, Missouri, 64128
VA Long Beach Healthcare System
Long Beach, California, 90822
Minneapolis VAHCS
Minneapolis, Minnesota, 55417
Philadelphia VA Medical Center
Philadelphia, Pennsylvania, 19104
About this study
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
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).
Read more
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.
- Conditions
- Hepatitis C
- Keywords
- Hepatitis C Genotype 1, Vitamin D, treatment-naive
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelaprevirDrug
Also called Incivek
Peginterferon alfa-2aDrug
Also called Pegasys
RibavirinDrug
Vitamin DDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| VitD+telaprevir+peginterferon+ribavirin | Active comparator | 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. Receives: Drug: Telaprevir; Drug: Peginterferon alfa-2a; Drug: Ribavirin; Dietary Supplement: Vitamin D |
| Telaprevir + Peginterferon + Ribavirin | Active comparator | Participants randomized to the control group immediately begin treatment with telaprevir + 180ug of peginterferon alfa-2a (Pegasys) per week and either weight based ribavirin. Receives: Drug: Telaprevir; Drug: Peginterferon alfa-2a; Drug: Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
HCV RNA
Hepatitis C virus Ribonucleic Acid identifies the presence of Hepatitis C in the blood
Measured: 4 weeks
Secondary outcomes (1)
adverse event profile
Cumulative record of unanticipated or unintended medical occurrences, not necessarily related to the study treatment.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Timothy Morgan, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Vertex Pharmaceuticals Incorporated
- Responsible party
- Sponsor-investigator, Timothy Morgan, MD, Southern California Institute for Research and Education
- Investigators
- Timothy R Morgan, MD, Principal investigator, Veterans Affairs Long Beach Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01890772
- Sponsor's protocol ID
- 1217
- Status last verified
- May 2014
- First submitted
- 31 May 2013
- Last updated
- 14 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01890772
- Acronym / sponsor ID
- 1217
- Conditions
- Hepatitis C
- Keywords
- Hepatitis C Genotype 1, Vitamin D, treatment-naive
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Timothy Morgan, MDUniversity, hospital or other
- Collaborators
- Vertex Pharmaceuticals Incorporated
- Study start
- Aug 2013
- Primary completion
- Oct 2015 (estimated)
- First posted
- 2 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VitD+telaprevir+peginterferon+ribavirin | Active comparator | Drug: Telaprevir, Drug: Peginterferon alfa-2a, Drug: Ribavirin, Dietary Supplement: Vitamin DParticipants 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 comparator | Drug: Telaprevir, Drug: Peginterferon alfa-2a, Drug: RibavirinParticipants randomized to the control group immediately begin treatment with telaprevir + 180ug of peginterferon alfa-2a (Pegasys) per week and either weight based ribavirin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chronic Hepatitis C genotype 1 infection
- Treatment naïve
- Age >18 years
- Agree to genetic testing
Key exclusion criteria (35 listed)
- Liver disease other than from hepatitis C
- HCV infection with mixed genotypes
- Decompensated liver disease
- AFP>100ng/ml.
- Known HIV infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelaprevirAlso: Incivek | Drug | Telaprevir + Peginterferon + Ribavirin, VitD+telaprevir+peginterferon+ribavirin |
| Peginterferon alfa-2aAlso: Pegasys | Drug | Telaprevir + Peginterferon + Ribavirin, VitD+telaprevir+peginterferon+ribavirin |
| Ribavirin | Drug | Telaprevir + Peginterferon + Ribavirin, VitD+telaprevir+peginterferon+ribavirin |
| Vitamin D | Dietary supplement | VitD+telaprevir+peginterferon+ribavirin |
Primary outcome
HCV RNA
Time frame: 4 weeks
Hepatitis C virus Ribonucleic Acid identifies the presence of Hepatitis C in the blood
1 secondary outcome
adverse event profile
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy R Morgan, MD principal investigator
Veterans Affairs Long Beach Healthcare
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Telaprevir, Peginterferon alfa-2a and Ribavirin in people with Hepatitis C, run by Timothy Morgan, MD at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HCV RNA (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2014.