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Hepatitis CPhase 4NCT00132210

Pegylated Interferon Therapy for Acute Hepatitis C Infection in HIV-infected Patients

A Phase 4 study testing pegylated interferon in people with Hepatitis C and HIV Infections, run by University Hospital, Bonn at 14 sites in Germany.

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

The purpose of this study is to determine whether pegylated interferon therapy is effective to treat acute hepatitis C infection in HIV-coinfected individuals. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Hepatitis C, HIV Infections
What is being tested?
pegylated interferon
How many people
200 participants
Where
14 sitesGermany
Study dates
Sep 2002to Jun 2010
Phase
Phase 4
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

  • Documented acute hepatitis C infection with detectable HCV-RNA (PCR-assay) and elevated serum alanine transferase (ALT) levels. An acute infection is defined by fulfilling two of the following 3 criteria within the preceding four months:
  • known or suspected exposure to HCV,
  • documented seroconversion to positivity for antibodies against HCV,
  • a serum alanine transferase (ALT) level of more than 350 U/l with a documented normal level during the year before infection.
  • Documented HIV-infection
  • CD4 cells > 300 /µl
  • Ability to understand and sign a written consent form
  • Women of child-bearing age: negative pregnancy test

Who cannot join

  • Autoimmune hepatitis or other autoimmune disease
  • Decompensated liver disease
  • Decompensated renal disease, i.e. creatinine clearance < 50 ml/min, according to Cockcroft-Gault
  • Acute or chronic hepatitis B infection
  • Acute infection with hepatitis A or other hepatotropic viruses
  • New AIDS defining event less than 1 month prior to enrolment
Show all 20Show fewer
  • Malignancy other than cutaneous kaposi sarcoma treated with systemic chemo-therapy
  • History of severe psychiatric conditions, in particular severe depression
  • History of seizures
  • History of organ transplantation
  • Thyroid disease not medically compensable
  • Severe heart disease
  • Severe retinopathy
  • Known allergy to the study drug or one of the galenic compounds
  • Hypersensitivity to interferon a
  • Thrombocytes < 90 G/l, neutrophils < 1.5 G/l, hemoglobin must not be < 12g/dl (female) or < 13 g/dl (male)
  • Treatment with corticosteroids less than 3 months prior to enrolment
  • Alcohol abuse or use of other recreational drugs
  • Older than 65 years of age, younger than 18 years of age
  • Pregnancy, breast-feeding

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

Germany14 sites

  • Practice Hintsche

    Berlin, 10117

  • Practice Bieniek

    Berlin, 10243

  • Practice Dupke/Carganico/Baumgarten

    Berlin, 10439

  • Practice Schranz

    Berlin, 10627

  • Practice Freiwald/Rausch

    Berlin, 10777

  • Practice Jessen

    Berlin, 10777

  • Practice Kluschke

    Berlin, 12047

  • Ärzteforum Seestraße

    Berlin, 13347

  • Practice Center Kaiserdamm

    Berlin, 14057

  • Medical Department I, University Hospital, Bonn University

    Bonn, 53127

  • Practice St. Georg

    Hamburg, 20099

  • Practice Fenske

    Hamburg, 20146

  • Practice Linnig

    Hamburg, 20359

  • Practice Trein

    Stuttgart, 70197

Other trials in Germany

About this study

The purpose of this study is to determine whether pegylated interferon therapy is effective to treat acute hepatitis C infection in HIV-coinfected individuals.

Read the detailed description

Background:HIV-infected individuals are at higher risk of developing a chronic course of hepatitis C after infection. Moreover, chronic hepatitis C is less well treatable in HIV-Coinfected than in hepatitis C monoinfected patients. There is basic research and clinical data on hepatitis C mono-infection supporting high sustained response rates of hepatitis C when treatment is started in the acute phase of infection.

Aim of the study: To determine whether pegylated interferon therapy is effective to treat acute hepatitis C infection in HIV-coinfected individuals.

Methods: Prospective, open-label, historical controlled trial. Eligible subjects are treated over 24 weeks with a pegylated interferon at standard dose. Weight-adjusted ribavirin comedication is recommended for HCV-genotypes 1 and 4. Treatment will be withheld for 12 weeks in order to allow spontaneous resolution in subjects with clinical symptomatic hepatitis C infection.

Being tested
pegylated interferon
Keywords
acute hepatitis C, HIV, pegylated interferon
Medical subject headings
Hepatitis C, HIV Infections

What participants receive

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

  • pegylated interferonDrug

    Also called Pegasys, PegIntron, Copegus, Rebetol

    Pegylated interferon alfa-2a or -2b in standard dosage Ribavirin in case of genotype 1 or 4 at 1000 or 1200 mg/d according to body weight ist recommended.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Negative hepatitis C ribonucleic acid (HCV-RNA) in peripheral serum

    Measured: Week 24

  2. Normal liver enzymes

    Measured: Week 24

Secondary outcomes (2)

  1. Negative HCV-RNA

    Measured: Week 12 and 48

  2. Normal liver enzymes

    Measured: Week 12 and 48

Timeline

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

  1. First posted19 Aug 2005 (estimated)
  2. Study startSep 2002
  3. Primary completionJun 2010
  4. Study completionJun 2010

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 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00132210
Sponsor's protocol ID
BN-102/02
Status last verified
Nov 2009
First submitted
17 Aug 2005
Last updated
21 Oct 2010
Results posted
No
Data monitoring committee
No

Publications

  • Vogel M, Bieniek B, Jessen H, Schewe CK, Hoffmann C, Baumgarten A, Kroidl A, Bogner JR, Spengler U, Rockstroh JK. Treatment of acute hepatitis C infection in HIV-infected patients: a retrospective analysis of eleven cases. J Viral Hepat. 2005 Mar;12(2):207-11. doi: 10.1111/j.1365-2893.2005.00580.x.

    PubMed 15720537

  • Vogel M, Nattermann J, Baumgarten A, Klausen G, Bieniek B, Schewe K, Jessen H, Boesecke C, Rausch M, Lutz T, Fenske S, Schranzo D, Kummerle T, Schuler C, Theisen A, Mayr C, Seidel T, Rockstroh JK. Pegylated interferon-alpha for the treatment of sexually transmitted acute hepatitis C in HIV-infected individuals. Antivir Ther. 2006;11(8):1097-101.

    PubMed 17302380

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing pegylated interferon in people with Hepatitis C and HIV Infections, run by University Hospital, Bonn at 14 sites in Germany.

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 8 inclusion and 20 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 21 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Germany. 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 phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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.

What does the primary outcome measure?

Negative hepatitis C ribonucleic acid (HCV-RNA) in peripheral serum (time frame: Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00132210, which also lists 2 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 21 Oct 2010; AzTrials last refreshed its copy on 7 Nov 2026.

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