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12 Week Study of Anti-Viral Effect of Oral UT-231B in Non-cirrhotic Hepatitis C Patients who have Failed Interferon-based Therapy. Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about 12 Week Study of Anti-Viral Effect of Oral UT-231B in Non-cirrhotic Hepatitis C Patients who have Failed Interferon-based Therapy. conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. 12 Week Study of Anti-Viral Effect of Oral UT-231B in Non-cirrhotic Hepatitis C Patients who have Failed Interferon-based Therapy. Clinical research trials and 12 Week Study of Anti-Viral Effect of Oral UT-231B in Non-cirrhotic Hepatitis C Patients who have Failed Interferon-based Therapy. health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including 12 Week Study of Anti-Viral Effect of Oral UT-231B in Non-cirrhotic Hepatitis C Patients who have Failed Interferon-based Therapy.. 12 Week Study of Anti-Viral Effect of Oral UT-231B in Non-cirrhotic Hepatitis C Patients who have Failed Interferon-based Therapy. Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a 12 Week Study of Anti-Viral Effect of Oral UT-231B in Non-cirrhotic Hepatitis C Patients who have Failed Interferon-based Therapy. clinical trial. Test subjects typically receive the most expert healthcare available for their 12 Week Study of Anti-Viral Effect of Oral UT-231B in Non-cirrhotic Hepatitis C Patients who have Failed Interferon-based Therapy. condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "1" Clinical Trials Conditions > 12 Week Study of Anti-Viral Effect of Oral UT-231B in Non-cirrhotic Hepatitis C Patients who have Failed Interferon-based Therapy. 12 Week Study of Anti-Viral Effect of Oral UT-231B in Non-cirrhotic Hepatitis C Patients who have Failed Interferon-based Therapy.
12 Week Study of Anti-Viral Effect of Oral UT-231B in Non-cirrhotic Hepatitis C Patients who have Failed Interferon-based Therapy.
For Condition: Hepatitis C
Status: Recruiting
Sponsor(s): United Therapeutics ,
Synopsis: This is a multi-center study. Neither the study subjects nor the physicians will know what treatment an individual subject is receiving. Subjects will be randomly assigned (like flipping a coin) to one of five treatment groups. The treatment groups include four different dosing groups of active study drug and one group of subjects who will receive placebo. A 12 week follow up period occurs after the 12 weeks of dosing. The study endpoint is a reduction in Hepatitis C viral load.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Patients must be adults, - have a positive Hepatitis C antibody test, - and be genotype 1, with a minimum of 100,000 IU of Hepatitis C virus by nucleic acid testing, be non-cirrhotic with a Metavir score of F0-3 (or equivalent) on liver biopsy, and have failed previous therapy with Interferon or Peg Interferon monotherapy, Interferon plus ribavirin, or Peg Interferon and ribavirin. Exclusion Criteria: - Diabetics are excluded.
Total Enrollment: 72
Location and Contact Information:
Overall Study Official:
KatrinaSwartz, Study Director, United Therapeutics
Beth Israel Deaconess Medical Center *Recruiting*
Boston, Massachusetts, 02215
United States
Recruiting Susanne Damitz 617-632-1073
Memphis Gastroenterology Group *Recruiting*
Memphis, Tennessee, 38120
United States
Recruiting Yvonne Shaw 901-747-3630
UNC Hospital *Recruiting*
Chapel Hill, North Carolina, 27599
United States
Recruiting Linda Anderson 919-843-0691
Shands Hospital at the University of Florida *Recruiting*
Gainesville, Florida, 32610-0214
United States
Recruiting Angie Martin 800-749-7424
VCU/MCV *Recruiting*
Richmond, Virginia, 23298
United States
Recruiting Jennifer Salvatori 804-827-0267
Tulane Univ. Health Sciences Center *Recruiting*
New Orleans, Louisiana, 70112
United States
Recruiting Delainna Bartholomew 504-585-6902
Additional Information:
Study ID Numbers: UT-231B-02:01;
Study Start Date: July 2003
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00069511
Other Hepatitis C Studies:
1. Thymosin Plus PEG-Interferon in Hepatitis C Patients with Cirrhosis Who Did Not Respond to Interferon or Interferon Plus Ribavirin
2. Treatment of Hepatitis C in Hemophilic Patients with HIV
3. Low-Dose Peginterferon and Ribavirin to Treat Chronic Hepatitis C in Patients Infected with HCV Genotype 2 or 3
4. Interleukin-2 (IL-2), Pegylated Interferon (PEG-IFN alfa-2b), and Ribavirin (RBV) Treatment in Patients with Hepatitis C and HIV Coinfection
5. 12 Week Study of Anti-Viral Effect of Oral UT-231B in Non-cirrhotic Hepatitis C Patients who have Failed Interferon-based Therapy.
Related Studies:
Other Hepatitis C Clinical Trials
Other Virginia Clinical Trials
Other Richmond Clinical Trials
12 Week Study of Anti-Viral Effect of Oral UT-231B in Non-cirrhotic Hepatitis C Patients who have Failed Interferon-based Therapy.
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