NCT00948220

Brief Summary

One single study has suggested that bone mineral density (BMD) is reduced in patients with non-cirrhotic chronic viral hepatitis C. Antiviral combination therapy with standard interferon and ribavirin may further decrease BMD. The aim of this study is to systematically investigate the effect of chronic hepatitis C genotype 1 infection alone and current standard therapy with peginterferon alfa-2a/ribavirin on BMD and bone metabolism.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2003

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 29, 2009

Completed
Last Updated

June 7, 2011

Status Verified

May 1, 2011

Enrollment Period

3.5 years

First QC Date

July 24, 2009

Last Update Submit

June 6, 2011

Conditions

Hepatitis C, ChronicLiver DiseasesVirus Diseases

Keywords

HCVhepatitis C virusCHCchronic hepatitis cinterferonribavirinDEXABMDbone mineral densityosteoporosisosteopeniaosteodystrophyosteodensitometryBone DensityHepatitis, Viral, HumanAnti-Infective Agentspeginterferon alfa-2a

Outcome Measures

Primary Outcomes (1)

  • Change of the bone mineral density of the lumbar spine and right hip measured by DEXA in patients with chronic hepatitis C with or without antiviral combination treatment with peginterferon and ribavirin

    96 weeks

Secondary Outcomes (1)

  • Change in markers of bone formation and resorption over time during antiviral therapy and after cessation of therapy.

    96 weeks

Study Arms (2)

Treatment

EXPERIMENTAL

Chronic hepatitis C patients on standard antiviral therapy with peginterferon alfa-2a and ribavirin

Drug: peginterferon alfa-2a and ribavirin

Control

NO INTERVENTION

Chronic hepatitis C patients without standard antiviral therapy

Interventions

peginterferon alfa-2a and ribavirinDRUG

standard antiviral therapy with peginterferon alfa-2a 180 µg/week and ribavirin 1000-1200 mg/d

Also known as: Pegasys, Copegus
Treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • proven chronic hepatitis C
  • aged between 18 and 65
  • male patients

You may not qualify if:

  • high grade liver fibrosis (Grade 3 - 4)
  • renal disease
  • hyperparathyroidism
  • hypogonadism
  • malignant disease
  • use of any other drug known to effect bone mineral metabolism
  • use of alcohol
  • organ transplant
  • any form of thyroid disease
  • any medical condition known to be associated with bone loss

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ulm

Ulm, 89081, Germany

Location

MeSH Terms

Conditions

Hepatitis C, ChronicLiver DiseasesVirus DiseasesHepatitis COsteoporosisBone Diseases, MetabolicHepatitis, Viral, Human

Interventions

peginterferon alfa-2aRibavirin

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

RibonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Michael Fuchs, MD

    University of Ulm

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 24, 2009

First Posted

July 29, 2009

Study Start

July 1, 2003

Primary Completion

January 1, 2007

Study Completion

March 1, 2008

Last Updated

June 7, 2011

Record last verified: 2011-05

Locations

DE(1)