Friday, June 29, 2018

Study # 7210 Newer Direct-Acting Anti-Viral Agents as Sole Therapy of Porphyria Cutanea Tarda in Subjects with Chronic Hepatitis C

Newer Direct-Acting Anti-Viral Agents as Sole Therapy of Porphyria Cutanea Tarda in Subjects with Chronic Hepatitis C

In order to participate in a study, you must personally contact 
the APF Edrin 1/866/APF/3635
For Diseases:
  • Porphyria Cutanea Tarda (PCT)

Background

Many people with PCT also have hepatitis C virus (HCV). There have been reports that the treatment of HCV infection can also resolve the symptoms of PCT. However, this has not been clearly established.
Therefore, the purpose of this study is to determine if giving a standard treatment for HCV is also an effective treatment for PCT.
The research aims are:
  1. To assess whether Harvoni (the treatment for HCV) alone is an effective and durable treatment for PCT in patients with both HCV and PCT.
  2. To determine whether treating patients with PCT and HCV with Harvoni is as effective as treating PCT with the standard therapies, phlebotomy or hydroxychloroquine.
This is a clinical trial, which means its purpose is to study an intervention or treatment. In this study all patients with PCT will be given a standard dose of Harvoni and monitored for two years. Currently there are two standard therapies for PCT, phlebotomies (removing certain amounts of blood at specific intervals), or low dose hydroxychloroquine (an oral pill). These treatments are used for patients with PCT whether or not they also have HCV. For patients with HCV however, we do not know whether treating the HCV first will also resolve the PCT symptoms.
There will be an initial visit to determine whether participants are eligible to be in the study. If a participant is found to be eligible, he/she will be asked come to the study site once every month over the course of one year, and then once every 3 months for an additional year. There will be approximately 17 visits over the course of the whole study. At these visits the study doctors will check in with the participant and some blood and urine samples will be taken. Participants will not be charged for any of the lab tests that are being done as a part of this study alone. All participants in this study will receive the Harvoni pills at no cost to them.

Targeted Enrollment

To be eligible to participate, you must:
  • Have a biochemical diagnosis of Porphyria Cutanea Tarda (PCT)
  • Have the typical symptoms of PCT (blistering in response to sun exposure, fragile skin, etc.)
  • Be at least 18 years old
  • Have chronic hepatitis C virus (HCV)
  • If you are female of child-bearing potential, you must be willing to take an effective method of contraception
You are not eligible to participate if you:
  • Are pregnant, planning to become pregnant, or breast-feeding
  • Used any other clinical or experimental therapy for PCT in the past month
  • Are currently enrolled in the Porphyrias Consortium study “Therapeutic Studies of PCT”
  • Have an HIV infection that is not well controlled
  • Drink more than 25 alcoholic drinks in a week
  • Have been taking a medication called amiodarone within 60 days of enrolling in this study
  • Have been taking St. John’s wort within 28 days or enrolling in this study
  • Have uncontrolled diabetes
  • Have chronic hepatitis B
  • Have other liver disease or have liver cancer
  • Have had a liver transplant in the past
  • Another disease or condition that the study doctors judge would interfere with the study
In order to participate in a study, you must personally contact the

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