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1 17th March 23:36
a.melon
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Posts: 1
Default Current Research Studies (1 Recruiting Patients) (diabetes bilirubin renal warfarin diet)


*IdB 1016 Treatment for Hepatitis C Disease*

*This study is currently recruiting patients*.

Sponsored by
National Center for Complementary and Alternative Medicine (NCCAM)

Purpose
This study will measure the safety and tolerability of three different doses of
IdB 1016 in patients with hepatitis C disease who have not responded to or are
poor candidates for interferon-based therapies.

NOTE: THE STUDY WILL ONLY RECRUIT STUDY PARTICIPANTS AT UNIVERSITY OF
WASHINGTON MEDICAL CENTER IN SEATTLE

Condition Treatment or Intervention Phase
Hepatitis C, Chronic
Drug: IdB 1016
Phase I
Phase II

MedlinePlus related topics: Hepatitis; Hepatitis C

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Dose Comparison, Parallel
Assignment, Safety/Efficacy Study

Official Title: IdB 1016 in Hepatitis C

Further Study Details:

Results from two open label and four randomized placebo-controlled studies in
patients with liver disease of diverse etiology suggest that IdB 1016 (oral
silybin-phosphatidylcholine phytosome) is well tolerated and significantly
improves serum liver enzyme levels. However, IdB 1016 dosing in these studies
ranged from 314 mg bid to 314 mg tid, which is below Phase I doses that were
well tolerated in healthy volunteers. None of the studies tested the safety and
efficacy of IdB 1016 strictly in patients with chronic hepatitis C disease or
measured post-treatment histologic changes.

This study will be an open label, randomized, dose-finding study. There will be
three arms corresponding to three different IdB 1016 doses: 314 mg, 624 mg, and
942 mg tid. Each arm will have 15 patients diagnosed with chronic hepatitis C
and will be stratified to five patients with fibrosis stage II (periportal
fibrosis), five patients with fibrosis stage III (bridging fibrosis), and five
patients with fibrosis stage IV (compensated cirrhosis). The treatment duration
will be 12 weeks. Patients will be followed for an additional 4 weeks after
treatment cessation to assess residual effects of measured parameters. Patients
will have clinic visits on Day -21 (screening), Day 1 (treatment initiation),
Day 29, Day 57, Day 85 (end of treatment), and Day 113 (follow-up after
washout).

Eligibility
Ages Eligible for Study: 18 Years - 65 Years, Genders Eligible for Study:
Both

Criteria
Inclusion Criteria:

* HCV infection according to ELISA-2
* Detectable HCV RNA PCR as measured within the previous 6 months
* Poor responders to, inadequate candidates for, or unwilling to use
interferon-based therapies
* Serum ALT >= 1.3 times above normal
* Persistently elevated serum ALT levels according to two measures in the
previous 12 months
* Evidence of stage II (periportal fibrosis), III (bridging fibrosis), or
IV (compensated cirrhosis) in the Batts-Ludwig scoring system according to a
liver biopsy performed in the last 2 (stage II and III patients) to 5 (stage IV
patients) years
* Able and willing to follow protocol directions for the duration of the
study
* Able and willing to maintain a consistent lifestyle routine (e.g., diet,
exercise, medications, and dietary supplements) and sleep schedule for the
duration of the study
* Able and willing to stop taking dietary supplements outside the study
protocol for the duration of the study
* Able and willing to practice two methods of contraception during the
study period, including the 4 week follow-up. This applies to women with
childbearing potential and men whose ***ual partners have childbearing
potential.

Exclusion Criteria:
* Pregnant or breastfeeding
* Liver synthetic dysfunction (albumin < 3.2 g/dL, total bilirubin > 3.0
mg/dL, prothrombin time > 1.5 seconds prolonged)
* History of portal hypertension, ascites, variceal bleeding,
encephalopathy, jaundice, or extrahepatic biliary obstruction
* History of uncontrolled diabetes mellitus
* Known concomitant acute or chronic viral liver infections (e.g.,
hepatitis A, hepatitis B, Epstein-Barr, or cytomegalovirus)
* Concomitant autoimmune and inflammatory disease (e.g., rheumatoid
arthritis, lupus)
* Other types of concomitant liver disease
* HIV-1 coinfection
* Chronic use of hepatotoxic drugs (e.g., acetaminophen)
* Interferon-based therapies in the past 6 months
* Alcohol consumption within 3 months prior to entry. Patients with a
history of alcohol abuse should be at least 2 years into recovery.
* Use of recreational oral or IV drugs. Patients with a history of drug
addiction should be at least 2 years into recovery.
* History of untreated malignancy
* Remission from previous malignant neoplasms <= 6 months
* History of significant renal, endocrine, cardiac, or pulmonary disease
* Use of supplements containing compounds derived from milk thistle
* Proven allergy to milk thistle or any derived compounds
* Subjects taking warfarin or coumadin due to silybin's potential
interactions with cytochrome CYP 29C
* Any condition or concomitant medication or supplement that could hinder
the outcomes of the study or the safety of the patient as determined by the
principal investigator

Expected Total Enrollment: 45

Location and Contact Information
Julie Bares 206-221-4138 julieb@medicine.washington.edu
Ellen Kilcourse 206-598-7839 ellenk@medicine.washington.edu
Washington
University of Washington Medical Center, Seattle, Washington, 98105,
United States; Recruiting
Kris V. Kowdley, M.D. 206-598-2076 kkowdley@u.washington.edu
Jose Berger, MF 425-602-3162 jberger@bastyr.edu
Kris V. Kowdley, M.D., Principal Investigator
Jose Berger, MF, Sub-Investigator

Study chairs or principal investigators
Kris V. Kowdley, M.D., Principal Investigator, University of Washington

Study ID Numbers 1 R21 AT00992-01A1; IdB-1016-UW-001
Study Start Date November 2003; Estimated Completion Date November 2004
Record last reviewed December 2003
NLM Identifier NCT00055445
ClinicalTrials.gov processed this record on 2004-05-21

*Evaluating Silymarin for Chronic Hepatitis C*

Purpose
To investigate the effect of silymarin, derived from the milk thistle plant,
Silybum marianum, in preventing and reversing the complications of chronic
infection with hepatitis C virus and/or clearing hepatitis C infections.
Condition Treatment or Intervention Phase
Hepatitis C, Chronic
Drug: Silymarin (milk thistle)
Phase II

MedlinePlus related topics: Hepatitis; Hepatitis C

Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control

Further Study Details:

The objective of this exploratory project is to assess the feasibility of
investigating the effect of silymarin, derived from the milk thistle plant,
Silybum marianum, in preventing and reversing the complications of chronic
infection with HCV and/or clearing HCV infections, thereby generating
preliminary results to serve as the basis of a more definitive study.
Allopathic the****utic interventions have not proved promising, particularly
with the genotype most commonly encountered in Egypt and they are prohibitively
expensive in the developing world. Egypt has the highest prevalence of HCV
infection in the world, averaging 15-25% in rural communities. There are
limited rigorous assessments of the dietary supplement milk thistle, but there
is promise of salutary effect. The specific aims are to evaluate whether
silymarin, the extract of milk thistle, can: (1) improves hepatic morbidity in
subjects with chronic HCV hepatitis and/or cirrhosis; (2) prevent progression
of liver disease in participants who have chronic HCV infections but who have
normal liver enzyme levels; (3) help clear HCV infections; and (4) improves
these participants' quality of life. Participants will be randomly assigned to
receive silymarin or a vitamin supplement (below antioxidant levels).
Participants will be recruited from a cohort of HCV-infected individuals
currently enrolled in a large observational study in Egypt. Participants will
receive the supplements daily for 18 months, with measures obtained every six
months. Measures to be assessed will include: retention in the study,
compliance with study assignment, self-described symptoms, alanine
aminotransferase (ALT) levels, serum collagen markers, abdominal ultrasound,
viral load and clearance, and quality of life (SF36 survey). It is hypothesized
that silymarin will not lead to clearance of HCV infections but can prevent
progression of liver disease in participants with chronic HCV hepatitis and, in
some cases, reverse hepatic lesions that are already present, as well as
improving the quality of life in individuals who use this dietary supplement.
This exploratory project is anticipated to result in successful initiation of
larger and more definitive studies of the effect of milk thistle on HCV
infection. Evidence of beneficial effect of an inexpensive and benign herbal
dietary supplement would have great impact on the large global population
suffering from chronic HCV infection.

More Information
Study ID Numbers 1 R21 AT00277-01
Study Start Date July 2000; Estimated Completion Date June 2002
Record last reviewed January 2002
NLM Identifier NCT00030030
ClinicalTrials.gov processed this record on 2004-05-21

*Herbal Treatment of Hepatitis C in Methadone Maintained Patients*

This study is no longer recruiting patients.

Sponsored by
National Center for Complementary and Alternative Medicine (NCCAM)

Purpose
Hepatitis C (HCV) is a chronic viral illness leading to progressive liver
damage that has emerged as a major public health issue in the United States.
While HCV affects all population groups, individuals with a history of
intravenous drug use form the largest known risk group. Between 90 and 100
percent of long term intravenous drug use will eventually test positive for
HCV, and there is substantial risk that even short term experimentation will
result in infection. Studies suggest that HCV will be the major cause of
cirrhosis and liver cancer in the next century. Currently, approved therapy
includes recombinant interferons, which lead to sustained remission in a
minority of patients. However, patients abusing other substances, including
alcohol, are not eligible for interferon therapy. The need for investigation
into other potential therapies is clear. Current practice patterns in the Far
East include the use of traditional herbal remedies for symptomatic chronic
viral hepatitis. This study is intended to examine the effect of commonly used
herbal remedies for the treatment of symptomatic HCV.
Condition Treatment or Intervention Phase
Hepatitis C
Drug: Herbal remedies
Phase II

MedlinePlus related topics: Hepatitis C

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control

Eligibility

Ages Eligible for Study: 18 Years - 70 Years, Genders Eligible for Study:
Both

Criteria

Inclusion Criteria:
* English speaking/reading
* Serum positive for HCV virus by PCR
* Elevated alanine transferase (ALT) within 6 months of the Entry Visit,
unattributable to causes other than HCV
* Liver biopsy within 2 years of entry confirming that the histological
diagnosis is consistent with chronic HCV
* Laboratory parameters available at the Entry Visit including CBC,
differential, and platelet count.


Location Information
Minnesota
Hennepin County Medical Center, Minneapolis, Minnesota, United States

Study chairs or principal investigators
Jeff Albrecht, MD, Principal Investigator, Hennepin County Medical Center -
Minneapolis

More Information
Study ID Numbers 8 P50 AT00009-02P3; 8 P50 AT00009-02; 5 P50 AT00009-03
Record last reviewed April 2002
NLM Identifier NCT00010816
ClinicalTrials.gov processed this record on 2004-05-21
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