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Hepatitis C, ChronicPEGHOPENCT01416610

An Observational Study of Pegasys (Peginterferon Alfa-2a) Plus Copegus (Ribavirin) in Participants With Chronic Hepatitis C (CHC), Genotype 2, 3, 1 or 4, Undergoing Opioid Maintenance Therapy

An observational study of Hepatitis C, Chronic, run by Hoffmann-La Roche at 10 sites in Austria.

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 prospective, multi-center, observational study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) plus Copegus (ribavirin) in participants with previously untreated chronic hepatitis C, genotype 2, 3, 1 or 4, who are undergoing opioid maintenance therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis C, Chronic
How many people
88 participants
Where
10 sitesAustria
Study dates
Apr 2010to Oct 2014
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Participants with chronic hepatitis C (CHC), Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy

Who may be able to join

  • Adult participants, >/= 18 years of age
  • Participants undergoing an opioid maintenance therapy
  • Serologic evidence of CHC prior to therapy
  • CHC genotype 2, 3, 1 or 4
  • Quantifiable serum hepatitis C (HCV) ribonucleic acid (RNA)
  • All fertile males and females receiving ribavirin must use two forms of effective contraception during treatment with study drugs and for 7 months after completion of treatment

Who cannot join

  • Harmful use of psychoactive substances (including excessive alcohol consumption) that precludes successful participation in the study at the discretion of the investigator
  • Pegylated interferon, standard interferon or ribavirin therapy at any time prior to initiation of the study
  • Co-infection with hepatitis A, hepatitis B or Human Immunodeficiency Virus (HIV)
  • Current diagnosis of a major depression or any psychotic disorder

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Austria10 sites

  • Lkh Hoergas-Enzenbach; Abt. Für Innere Medizin

    Gratwein, 8112

  • Lkh-Univ. Klinikum Graz

    Graz, 8036

  • Lkh innsbruck - univ. Klinikum innsbruck - Tiroler landeskrankenanstalten ges.m.b.h.; Innere Medizin

    Innsbruck, 6020

  • Klinikum Klagenfurt am Wörthersee; 2. Medizinische Abteilung

    Klagenfurt, 9020

  • A.Ö. Krankenhaus Der Elisabethinen Linz; Iv. Med. Abtl.

    Linz, 4010

  • Gesundheitszentrum Wien Mitte

    Vienna, 1030

  • Krankenanstalt Rudolfstiftung; Iv. Med. Abtl.

    Vienna, 1030

  • Medizinische Universität Wien; Univ.Klinik für Innere Medizin III - Gastroenterologie & Hepatologie

    Vienna, 1090

  • Kaiser Franz Josef Spital; Iv. Medizinische Abt.

    Vienna, 1100

  • Wilhelminenspital; 6. Medizinische Abteilung Wilhelminenspital; 6. Medizinische Abteilung

    Vienna, 1160

Other trials in Austria

About this study

Official title: A Prospective, Observational, Multicenter Non-interventional Trial Examining Efficacy of Combination Therapy With PEGASYS® (Peginterferon Alfa-2a 40KD) Plus COPEGUS® (Ribavirin) in Patients With Chronic Hepatitis C, Genotype 2, 3, 1 or 4, Undergoing an Opioid Maintenance-Therapy With Special Focus on Patient Compliance and Quality of Life

This prospective, multi-center, observational study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) plus Copegus (ribavirin) in participants with previously untreated chronic hepatitis C, genotype 2, 3, 1 or 4, who are undergoing opioid maintenance therapy. Data will be collected from eligible participants receiving Pegasys and Copegus treatment as prescribed by treating physician and treatment-free follow-up period of 24 weeks.

Medical subject headings
Hepatitis C, Chronic

What participants receive

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

Study groups in NCT01416610
Study groupRoleWhat they receive
All ParticipantsParticipants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy

What is being measured

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

  1. Percentage of Participants With Sustained Virological Response 24 Weeks After Completing Treatment (SVR24)

    SVR24 is defined as percentage of participants with undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) 24 weeks after completing treatment, using a last observation carried forward (LOCF) approach. Percentage is based on the number of non-missing observations (total).

    Measured: 24 weeks after completing treatment, within 3 years, 6 months

Secondary outcomes (7)

  1. Percentage of Participants With SVR 12

    SVR 12 is defined as percentage of participants with undetectable HCV RNA 12 weeks after completing treatment, using a LOCF approach. Percentage is based on the number of non-missing observations (total).

    Measured: 12 weeks after completing treatment, within 3 years, 6 months

  2. Percentage of Participants With End of Treatment Response

    A participant was considered to have end of treatment response if there was undetectable HCV RNA after completing treatment, using a LOCF approach. Percentage is based on the number of non-missing observations (total).

    Measured: at end of treatment, within 3 years, 6 months

  3. Percentage of Participants With Virological Relapse

    Virological relapse is defined as no SVR24 in a participant with undetectable HCV RNA at end of treatment who has at least one post-treatment polymerase chain reaction (PCR) result available, using a LOCF approach. Percentage is based on the number of non-missing observations (total).

    Measured: by end of follow-up, within 3 years, 6 months

  4. Short Form Health Survey (SF-36) Scores by Visit

    The SF-36 questionnaire items were scored and transformed according to the SF-36 Health Survey Manual \& Interpretation Guide. Summary scores for SF-36 dimensions of physical functioning, role functioning, bodily pain, general health, vitality, social functioning, and mental health were scored on a scale of 0 (worst) to 100 (best), and health transition was scored on a scale of 0 (worst) to 5 (best). Summary SF-36 scores are reported by category and by visit.

    Measured: at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months

  5. Fatigue Severity Scale (FSS) Score by Visit

    The Fatigue Severity Scale (FSS) consists of 9 questions, each answered within a range of 1-7, where lower scores indicate less fatigue in everyday life. The FSS score is the mean of the 9 numbers. Mean scores are presented by visit.

    Measured: at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months

  6. Beschwerdeliste (BL) Score by Visit

    The BL questionnaire items were scored by calculating the average response to all answered items. Items can be graded 1="stark" (affliction is strong) to 4="gar nicht" (not present). The higher the BL score, the less afflictions were present for a participant. Mean scores are presented by visit.

    Measured: at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months

  7. Beck Depression Inventory (BDI) Score by Visit

    The BDI questionnaire items were scored by generating the sum of the responses to all answered items. Each result was categorized into one of four categories: 0-13= no depression or clinically not significant or in remission; 14-19= mild depression; 20-28= moderate depression; or 29-63= severe depression. Mean scores are presented by visit.

    Measured: at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months

Timeline

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

  1. First posted15 Aug 2011 (estimated)
  2. Study startApr 2010
  3. Primary completionOct 2014
  4. Study completionOct 2014

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01416610
Sponsor's protocol ID
ML25159
Acronym
PEGHOPE
Status last verified
Mar 2017
First submitted
12 Aug 2011
Last updated
10 Apr 2017
Data monitoring committee
No

Publications

  • Gschwantler M, Laferl H, Vogel W, Korak W, Moser S, Hofer H, Bauer B, Schleicher M, Bognar B, Bischof M, Stauber R, Maieron A, Ferenci P; Austrian Hepatitis Study Group. Efficacy of peginterferon plus ribavirin in patients receiving opioid substitution therapy : Final results of the Austrian PegHope study. Wien Klin Wochenschr. 2018 Jan;130(1-2):54-61. doi: 10.1007/s00508-017-1263-2. Epub 2017 Sep 12.

    PubMed 28900714

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatitis C, Chronic, run by Hoffmann-La Roche at 10 sites in Austria.

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 6 inclusion and 4 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 10 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Austria. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants With Sustained Virological Response 24 Weeks After Completing Treatment (SVR24) (time frame: 24 weeks after completing treatment, within 3 years, 6 months). 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 NCT01416610, which also lists 1 linked publication.

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 10 Apr 2017.

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