NCT00910975

Brief Summary

The purpose of the study is to investigate if the duration of treatment of hepatitis C with pegylated interferon and ribavirin can be individualized on the basis of how fast the hepatitis C virus concentration in the blood decreases, and if this is more cost-efficient than standard treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2007

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

November 1, 2007

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

May 28, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

September 5, 2012

Status Verified

September 1, 2012

Enrollment Period

2.6 years

First QC Date

May 28, 2009

Last Update Submit

September 3, 2012

Conditions

Chronic Hepatitis C, Genotype 1

Keywords

Hepatitis C virusReal-time PCRTreatment

Outcome Measures

Primary Outcomes (1)

  • Medication dose per cured patient

    26 weeks after end of treatment

Secondary Outcomes (1)

  • Sustained virological response and relapse rate

    26 weeks after end of treatment

Study Arms (2)

Standard of care

ACTIVE COMPARATOR

Treatment with Pegasys 180 µg/week and ribavirin 1000/1200 mg per day. Treatment is given for 24, 48 or 72 weeks depending on the time point (week 4, 12 or 24) when HCV RNA becomes undetectable by the Cobas Taqman assay. If HCV RNA has not declined 2 logs by week 12 or is detectable at week 24, treatment is stopped.

Drug: Peg-interferon-alfa2a (Pegasys)Drug: Ribavirin (Copegus)

Tailored treatment

EXPERIMENTAL

Treatment with Pegasys 180 µg/week and ribavirin 1000/1200 mg per day. Treatment duration is flexible, 24-72 weeks, depending on the time point when the HCV RNA level is calculated to be 1 copy/mL. If the decline between day 14 and 28 is poor, treatment is stopped after 5 weeks.

Drug: Peg-interferon-alfa2a (Pegasys)Drug: Ribavirin (Copegus)

Interventions

Peg-interferon-alfa2a (Pegasys)DRUG

Peg-interferon-alfa2a 180 µg per week

Also known as: Pegasys
Standard of careTailored treatment
Ribavirin (Copegus)DRUG

Ribavirin 1000 or 1200 mg per day depending on if body weight is below or above 75 kg

Standard of careTailored treatment

Eligibility Criteria

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

You may qualify if:

  • Anti-HCV positive for \> 6 months
  • Genotype 1
  • Clinical indication for treatment, preferably a liver biopsy showing significant inflammation and/or fibrosis
  • Negative pregnancy test (for fertile women)

You may not qualify if:

  • Pregnancy or breast-feeding
  • Antiviral or immune modulating treatment the last 6 months
  • Hepatitis B or HIV infection (HBsAg, anti-HIV)
  • Other significant chronic liver disease
  • History of bleeding esophageal varices or other signs of decompensation
  • Neutrophiles \< 1.0 x 109/L or platelets \< 50 x 109/L. S-creatinine \> 2 x ULN
  • History of severe psychiatric disorder
  • Autoimmune disease, severe heart disease, previous organ or stem cell transplantation, malignancy, thyroid disease, severe retinopathy
  • Drug abuse, current or during the last year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, Västra Götaland County, 41346, Sweden

Location

Related Publications (1)

  • Lindh M, Alestig E, Arnholm B, Eilard A, Hellstrand K, Lagging M, Wahlberg T, Wejstal R, Westin J, Norkrans G. Response prediction and treatment tailoring for chronic hepatitis C virus genotype 1 infection. J Clin Microbiol. 2007 Aug;45(8):2439-45. doi: 10.1128/JCM.00577-07. Epub 2007 Jun 20.

    PMID: 17581934BACKGROUND

MeSH Terms

Conditions

Hepatitis C, ChronicHepatitis C

Interventions

peginterferon alfa-2aRibavirin

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RibonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Magnus Lindh, MD, PhD

    Sahlgrenska University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2009

First Posted

June 1, 2009

Study Start

November 1, 2007

Primary Completion

June 1, 2010

Study Completion

September 1, 2011

Last Updated

September 5, 2012

Record last verified: 2012-09

Locations

SE(1)