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Hepatitis C, ChronicPhase 4NCT00087594

A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With Copegus (Ribavirin) in Patients With Chronic Hepatitis C (CHC) Enrolled in a Methadone Maintenance Treatment Program.

A Phase 4 study testing peginterferon alfa-2a [Pegasys] and ribavirin in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 7 sites 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 evaluate the safety and tolerability of PEGASYS plus ribavirin in previous intravenous (iv) drug users who have CHC and are currently enrolled in a methadone maintenance treatment program. The anticipated time on study treatment is 1-2 years, and the target sample size is <100 individuals. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis C, Chronic
What is being tested?
peginterferon alfa-2a [Pegasys] and ribavirin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
7 sitesUnited States
Study dates
Nov 2003to Oct 2006
Phase
Phase 4
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

Who may be able to join

  • adult patients at least 18 years of age
  • CHC infection, genotype 1, 2, or 3
  • naive to treatment for CHC infection
  • enrolled in a methadone maintenance program with documented attendance for at least 3 months
  • use of 2 forms of contraception during the study on both men and women

Who cannot join

  • previous treatment for CHC infection
  • co-infection with human immunodeficiency virus (HIV)
  • current use of IV or other illicit drugs
  • decompensated cirrhosis
  • women who are pregnant or breastfeeding

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites
  • Study site

    Baltimore, Maryland, 21205

  • Study site

    Downers Grove, Illinois, 60515

  • Study site

    Farmington, Connecticut, 06030

  • Study site

    Honolulu, Hawaii, 96813

  • Study site

    New York, New York, 10003

  • Study site

    Richmond, Virginia, 23249

  • Study site

    San Francisco, California, 94121

Other trials in United States

About this study

Official title: An Open-Label, Multi-Center, Randomized, Safety, Feasibility and Tolerability Pilot Study of Pegasys® (Peginterferon Alfa-2a) Plus Copegus® (Ribavirin) in Previous Intravenous Drug Users Who Are Currently Enrolled in a Methadone Maintenance Treatment Program.

This study will evaluate the safety and tolerability of PEGASYS plus ribavirin in previous intravenous (iv) drug users who have CHC and are currently enrolled in a methadone maintenance treatment program. The anticipated time on study treatment is 1-2 years, and the target sample size is <100 individuals.

Being tested
peginterferon alfa-2a [Pegasys], ribavirin
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.

  • peginterferon alfa-2a [Pegasys]Drug

    180 micrograms sc weekly for 24 weeks (G 2/3) or 48 weeks (G 1)

  • ribavirinDrug

    1000/1200mg (< or >= 75 kg, respectively), po in two doses daily for 48 weeks (G 1) or 800 mg po in two doses daily for 24 weeks (G 2/3)

Study groups in NCT00087594
Study groupRoleWhat they receive
Direct Observed TherapyExperimentalParticipants will receive the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 microgram (mcg) (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 milligram (mg)/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
Receives: Drug: peginterferon alfa-2a [Pegasys]; Drug: ribavirin
Self-Administration TherapyExperimentalParticipants will receive the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
Receives: Drug: peginterferon alfa-2a [Pegasys]; Drug: ribavirin

What is being measured

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

  1. Number of Participants With Treatment Completion Rate (TCR)

    TCR is defined as the number of participants who completed the prescribed duration of the study treatment. TCR for G1 participants is defined as the number of participants who had a missing value or >= 2-log10 decrease in Hepatitis C virus-ribonucleic acid (HCV RNA) at Week 12 and completed 48 weeks of study treatment or had a < 2-log10 decrease from baseline at Week 12 and completed at least 12 weeks of study treatment. TCR for G2/ 3 participants is defined as the number of participants who completed 24 weeks of study treatment.

    Measured: Up to 24 weeks for G2/3; up to 48 weeks for G1

Secondary outcomes (13)
  1. Number of Participants With Sustained Virological Response (SVR) Rate at 24 Weeks Post Treatment (Week 48 for G2/3 and Week 72 for G1)

    SVR is defined as the number of participants with undetectable HCV-RNA (< 10 international unit per milliliter [IU/mL]) at 24 weeks post treatment completion.

    Measured: Week 48 for G2/3 and Week 72 for G1

  2. Number of Participants With Virological Response Rate at Weeks 12, 24, and 48 (G1 Only) During Treatment and at 12 Weeks After Treatment Completion

    Virological Response Rate is defined as the number of participants with undetectable HCV-RNA (< 10 IU/mL). Treatment completion (end of treatment [EOT]) for G1 was Week 48 and for G2 or 3 was Week 24.

    Measured: Weeks 12, 24, and 48 for G1 and Weeks 12 and 24 for G2/3; 12 and 24 weeks after EOT for G1 (Weeks 60 and 72) and G2/3 (Weeks 36 and 48)

  3. Number of Participants With Biochemical Response Rate at Weeks 12, 24, and 48 (G1 Only) During Treatment and at 12 and 24 Weeks After Treatment Completion

    Biochemical response is defined as the number of participants with a normal serum alanine aminotransferase (ALT) concentration (i.e., ALT < 30 U/L). EOT for G1 was Week 48 and for G2/3 was Week 24.

    Measured: Weeks 12, 24, and 48 for G1 and Weeks 12 and 24 for G2/3; 12 and 24 weeks after EOT for G1 (Weeks 60 and 72) and G2/3 (Weeks 36 and 48)

  4. Number of Participants With > =2 Log Drop From Baseline or Undetectable HCV-RNA (<10 IU/mL) at Week 12

    Measured: Week 12

  5. Mean Absolute Score of Beck Depression Inventory, Second Edition (BDI-II)

    BDI-II is 21-item self-report instrument to assess severity of symptoms of depression. There is a four-point scale for each item ranging from 0 to 3. Degrees of depression defined by the total BDI-II score as: minimal (0 to 13), mild (14 to 19), moderate (20 to 28), and severe depression (>= 29). Higher scores reflective of greater severity (worse outcome).

    Measured: Baseline (Day -30 to -1), EOT visit (Week 24 for G2/3 and Week 48 for G1), and end of study (EOS) visit (Week 48 for G2/3 and Week 72 for G1).

  6. Mean Change From Baseline in BDI-II Score to EOT (Week 24/48) and EOS (Week 48/72) Visits

    BDI-II is 21-item self-report instrument to assess severity of symptoms of depression. There is a four-point scale for each item ranging from 0 to 3. Degrees of depression defined by the total BDI-II score as: minimal (0 to 13), mild (14 to 19), moderate (20 to 28), and severe depression (>= 29). Higher scores reflective of greater severity (worse outcome).

    Measured: Baseline (Day -30 to -1), EOT visit (Week 24 for G2/3 and Week 48 for G1), and end of study (EOS) visit (Week 48 for G2/3 and Week 72 for G1)

  7. Number of Participants With Degrees of Depression as Defined by the BDI-II Score

    Participants with degrees of depression as defined by the BDI-II Score were reported. BDI-II is 21-item self-report instrument to assess severity of symptoms of depression. There is a four-point scale for each item ranging from 0 to 3. Degrees of depression defined by the total BDI-II score as: minimal (0 to 13), mild (14 to 19), moderate (20 to 28), and severe depression (>= 29). Higher scores reflective of greater severity (worse outcome).

    Measured: Up to Week 72

  8. Mean Absolute Scores for Hepatitis Quality-of-Life Questionnaire (HQLQ) at EOT (Week 24/48) Visit and 24 Weeks After EOT Visit

    The HQLQ is a multiple-choice questionnaire includes the eight individual qualify-of-life scales of the Medical Outcomes Study 36-item Short-form Health Survey as: Social functioning (SF), role limitations due to emotional problems (RE), vitality (VT), general mental health (MH), physical functioning (PF), role limitations due to physical problems (RP), freedom from bodily pain (BP), and general health (GH). In addition, two other generic scales (positive well-being [PWB] and health distress [HD]) and two hepatitis-specific scales (limitations because of chronic hepatitis C [HLIM] and health distress because of chronic hepatitis C [HHD]) were included. Scores were scaled to a 0 to 100 range, with 0 = bad and 100 = good. A higher score indicates an improvement.

    Measured: Baseline (Day -30 to -1), 24 weeks after EOT visit (Week 48 for G2/3 and Week 72 for G1)

  9. Number of Participants With Compliance to the Prescribed Treatment Regimen

    Participants with compliance to the prescribed treatment regimen for peginterferon alfa-2a and ribavirin was reported. Compliance was calculated as (total cumulative dose taken) / (total cumulative original dose prescribed for the entire study) x 100. Total treatment duration = Maximum doses of peginterferon alfa-2a and ribavirin in days / (48*7) for G1, total treatment duration = Maximum doses of peginterferon alfa-2a and ribavirin in days / (24*7) for G2/3.

    Measured: Up to Week 24 for G 2/3; up to Week 48 for G1

  10. Number of Participants With Abnormal Vital Signs

    Vital Signs included systolic blood pressures (SBP), diastolic blood pressures (DBP), and pulse rate (PR). Abnormal vital signs were reported as low or high abnormal. It was defined as < 85 mm Hg or > 180 mm Hg with a change from baseline of > 20%; DBP as > 110 mm Hg with a change from baseline of > 20%; and PR as < 50 bpm and > 120 bpm with a change from baseline of > 20%.

    Measured: Up to 24 weeks of treatment-free follow-up visit (Week 48 for G2/3 and Week 72 for G1)

  11. Number of Participants With Marked Laboratory Abnormalities (Hematology)

    Hematology included hematocrit (fraction), hemoglobin, platelets count, Red blood cells (RBC), White blood cell (WBC), eosinophils, lymphocytes, monocytes, neutrophils, Partial Thromboplastin time (PTT), Prothrombin Time International Normalized Ratio (PT INR). Laboratory values falling outside the marked reference range as defined by Roche's "International Guideline for the Handling and Reporting of Laboratory Data", and were clinically relevant change from baseline were considered marked laboratory abnormalities. It was reported as low or high abnormal.

    Measured: Up to 24 weeks post treatment (Week 48 for G2/3 and Week 72 for G1)

  12. Number of Participants With Marked Laboratory Abnormalities (Biochemistry)

    Laboratory values falling outside the marked reference range as defined by Roche's "International Guideline for the Handling and Reporting of Laboratory Data", and were clinically relevant change from baseline were considered marked laboratory abnormalities. It was reported as low or high abnormal.

    Measured: Up to 24 weeks post treatment (Week 48 for G2/3 and Week 72 for G1)

  13. Number of Participants With Any Adverse Events (AEs), Any Serious Adverse Events (SAEs), and Study Discontinuation

    An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect. Reason for discontinuation was categorized as safety and non-safety, where safety reasons included abnormality of laboratory tests, AEs, and death; and non-safety reasons included insufficient therapeutic response, early improvement, violation of selection criteria at entry, other protocol violation, refused treatment, failure to return and other. Participants who discontinued the study with any reason were recorded.

    Measured: Up to 24 weeks post treatment (Week 48 for G2/3 and Week 72 for G1)

Timeline

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

  1. First posted14 Jul 2004 (estimated)
  2. Study startNov 2003
  3. Primary completionOct 2006
  4. Study completionOct 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 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00087594
Sponsor's protocol ID
ML17251
Status last verified
Feb 2016
First submitted
12 Jul 2004
Last updated
4 Mar 2016

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing peginterferon alfa-2a [Pegasys] and ribavirin in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 7 sites 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 5 inclusion and 5 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 4 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites 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 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?

Yes. Results are posted in the registry (first posted 4 Mar 2016). 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?

Number of Participants With Treatment Completion Rate (TCR) (time frame: Up to 24 weeks for G2/3; up to 48 weeks for G1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 4 Mar 2016.

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