Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Vertex Pharmaceuticals Incorporated | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telaprevir | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| HCV RNA | Hepatitis C virus Ribonucleic Acid identifies the presence of Hepatitis C in the blood | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| adverse event profile | Cumulative record of unanticipated or unintended medical occurrences, not necessarily related to the study treatment. | 12 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Timothy R Morgan, MD | Veterans Affairs Long Beach Healthcare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Long Beach Healthcare System | Long Beach | California | 90822 | United States | ||
| Minneapolis VAHCS |
Not provided
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
Not provided
Not provided
| ID | Term |
|---|---|
| C486464 | telaprevir |
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012632 | Secosteroids |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Peginterferon alfa-2a | Drug |
|
|
| Ribavirin | Drug |
|
| Vitamin D | Dietary Supplement |
|
| 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 |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |