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

2014年5月13日 更新者:Timothy Morgan, MD

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).

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.

研究概览

研究类型

介入性

阶段

  • 阶段2
  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • California
      • Long Beach、California、美国、90822
        • VA Long Beach Healthcare System
    • Minnesota
      • Minneapolis、Minnesota、美国、55417
        • Minneapolis VAHCS
    • Missouri
      • Kansas City、Missouri、美国、64128
        • Kansas City VA Medical Center
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19104
        • Philadelphia VA Medical Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
有源比较器: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.
其他名称:
  • 飞马座
其他名称:
  • 因西韦克
有源比较器: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.
其他名称:
  • 飞马座
其他名称:
  • 因西韦克

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
HCV RNA
大体时间:4 weeks
Hepatitis C virus Ribonucleic Acid identifies the presence of Hepatitis C in the blood
4 weeks

次要结果测量

结果测量
措施说明
大体时间
adverse event profile
大体时间:12 weeks
Cumulative record of unanticipated or unintended medical occurrences, not necessarily related to the study treatment.
12 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Timothy R Morgan, MD、Veterans Affairs Long Beach Healthcare

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2013年8月1日

初级完成 (预期的)

2015年10月1日

研究注册日期

首次提交

2013年5月31日

首先提交符合 QC 标准的

2013年6月27日

首次发布 (估计)

2013年7月2日

研究记录更新

最后更新发布 (估计)

2014年5月14日

上次提交的符合 QC 标准的更新

2014年5月13日

最后验证

2014年5月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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