AzTrials
AzTrials

Hepatitis C, ChronicPhase 1/2NCT00055445

IdB 1016 Treatment for Hepatitis C Disease

A Phase 1/2 study testing IdB 1016 in people with Hepatitis C, Chronic, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Hepatitis C, Chronic
What is being tested?
IdB 1016
How many people
45 participants
Where
1 siteUnited States
Study dates
Nov 2003to Apr 2006
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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. Patients with clinical signs of compensated cirrhosis (portal hypertension, non-bleeding varices) do not require a biopsy.
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  • 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 sexual partners have childbearing potential.

Who cannot join

  • 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 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)
Show all 19Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Washington Medical Center

    Seattle, Washington, 98105

Other trials in United States

About this study

Official title: IdB 1016 in Hepatitis C

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

Read the detailed description

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).

Being tested
IdB 1016
Keywords
Complementary Therapies, IdB 1016, Silybin, Antioxidant, Hepatitis C Virus, Phosphatidylcholine
Medical subject headings
Hepatitis C, Chronic, Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IdB 1016Drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2003 (estimated)
  2. Study startNov 2003
  3. Study completionApr 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
45 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00055445
Sponsor's protocol ID
R21AT000992-01A1
Other IDs
IdB-1016-UW-001
Status last verified
Jul 2006
First submitted
3 Mar 2003
Last updated
18 Aug 2006
Results posted
No

Publications

  • Carini R, Comoglio A, Albano E, Poli G. Lipid peroxidation and irreversible damage in the rat hepatocyte model. Protection by the silybin-phospholipid complex IdB 1016. Biochem Pharmacol. 1992 May 28;43(10):2111-5. doi: 10.1016/0006-2952(92)90168-i.

    PubMed 1599497

  • Comoglio A, Tomasi A, Malandrino S, Poli G, Albano E. Scavenging effect of silipide, a new silybin-phospholipid complex, on ethanol-derived free radicals. Biochem Pharmacol. 1995 Oct 12;50(8):1313-6. doi: 10.1016/0006-2952(95)02001-s.

    PubMed 7488251

  • Conti M, Malandrino S, Magistretti MJ. Protective activity of silipide on liver damage in rodents. Jpn J Pharmacol. 1992 Dec;60(4):315-21. doi: 10.1254/jjp.60.315.

    PubMed 1287266

  • Edwards J, Grange LL, Wang M, Reyes E. Fetoprotectivity of the flavanolignan compound siliphos against ethanol-induced toxicity. Phytother Res. 2000 Nov;14(7):517-21. doi: 10.1002/1099-1573(200011)14:73.0.co;2-w.

    PubMed 11054841

  • Morazzoni P, Montalbetti A, Malandrino S, Pifferi G. Comparative pharmacokinetics of silipide and silymarin in rats. Eur J Drug Metab Pharmacokinet. 1993 Jul-Sep;18(3):289-97. doi: 10.1007/BF03188811.

    PubMed 8149949

  • Morazzoni P, Magistretti MJ, Giachetti C, Zanolo G. Comparative bioavailability of Silipide, a new flavanolignan complex, in rats. Eur J Drug Metab Pharmacokinet. 1992 Jan-Mar;17(1):39-44. doi: 10.1007/BF03189986.

    PubMed 1499596

  • Comoglio A, Leonarduzzi G, Carini R, Busolin D, Basaga H, Albano E, Tomasi A, Poli G, Morazzoni P, Magistretti MJ. Studies on the antioxidant and free radical scavenging properties of IdB 1016 a new flavanolignan complex. Free Radic Res Commun. 1990;11(1-3):109-15. doi: 10.3109/10715769009109673.

    PubMed 2074043

  • Barzaghi N, Crema F, Gatti G, Pifferi G, Perucca E. Pharmacokinetic studies on IdB 1016, a silybin- phosphatidylcholine complex, in healthy human subjects. Eur J Drug Metab Pharmacokinet. 1990 Oct-Dec;15(4):333-8. doi: 10.1007/BF03190223.

    PubMed 2088770

  • Schandalik R, Perucca E. Pharmacokinetics of silybin following oral administration of silipide in patients with extrahepatic biliary obstruction. Drugs Exp Clin Res. 1994;20(1):37-42.

    PubMed 7924893

  • Schandalik R, Gatti G, Perucca E. Pharmacokinetics of silybin in bile following administration of silipide and silymarin in cholecystectomy patients. Arzneimittelforschung. 1992 Jul;42(7):964-8.

    PubMed 1329780

  • Buzzelli G, Moscarella S, Giusti A, Duchini A, Marena C, Lampertico M. A pilot study on the liver protective effect of silybin-phosphatidylcholine complex (IdB1016) in chronic active hepatitis. Int J Clin Pharmacol Ther Toxicol. 1993 Sep;31(9):456-60.

    PubMed 8225695

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing IdB 1016 in people with Hepatitis C, Chronic, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00055445, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2006.

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