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Hepatitis C, ChronicPhase 4NCT02864199

A Study of Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) Combination Therapy in Participants With Chronic Hepatitis C (CHC) and Various Degrees of Renal Impairment

A Phase 4 study testing Peginterferon alfa-2a and Ribavirin in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 17 sites in 5 countries.

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 pharmacokinetics (area under the curve [AUC], maximum concentration [Cmax], and other parameters) and tolerability of peginterferon alfa-2a and ribavirin combination therapy following single and multiple doses in participants with CHC infection and moderate to severe renal impairment or… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Hepatitis C, Chronic
What is being tested?
Peginterferon alfa-2a and Ribavirin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
17 sitesin 5 countries
Study dates
Feb 2004to Sep 2007
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

  • Adults 18 to 65 years of age
  • CHC infection as shown on enzyme-linked immunosorbent assay (ELISA) and radioimmunoblot assay (RIBA) or quantifiable hepatitis C virus (HCV) ribonucleic acid (RNA) greater than (>) 2000 copies per milliliter (copies/mL)
  • Use of two forms of contraception during study and 6 months after the study in both men and women
  • Normal renal function (creatinine clearance [CrCl] >80 milliliters per minute [mL/min]), moderate renal impairment (CrCl 30 to 50 mL/min), severe renal impairment (CrCl less than [<] 30 mL/min), or ESRD requiring hemodialysis
  • Patients with ESRD must have been undergoing hemodialysis for at least 2 months

Who cannot join

  • Women who are pregnant or breastfeeding
  • Male partners of women who are pregnant
  • Conditions associated with decompensated and/or chronic liver disease
  • Human immunodeficiency virus (HIV) infection
  • Interferon or ribavirin treatment within the previous 3 months
  • Poor hematologic function, including unstable hemoglobin
  • Significant comorbidity or severe illness which would make the participant unsuitable for the study
  • Acute renal failure

Trial locations and contacts

17 sites in 5 countries.

17 sites in 5 countries

United States12 sites

  • Study site

    Birmingham, Alabama, 35294

  • Study site

    Cleveland, Ohio, 44106

  • Study site

    Dallas, Texas, 75203

  • Study site

    Galveston, Texas, 77555

  • Study site

    Kansas City, Kansas, 66160

  • Study site

    Kansas City, Missouri, 64128

  • Study site

    New Orleans, Louisiana, 70112

  • Study site

    New York, New York, 10029

  • Study site

    Pittsburgh, Pennsylvania, 15213

  • Study site

    Portland, Oregon, 97239

  • Study site

    St Louis, Missouri, 63110

  • Study site

    Syracuse, New York, 13210

Other trials in United States

New Zealand2 sites

  • Study site

    Christchurch, 8011

  • Study site

    Riccarton, Christchurch, 8011

Other trials in New Zealand

Brazil1 site

  • Study site

    São Paulo, 04038-002

Other trials in Brazil

France1 site

  • Study site

    Marseille, 13285

Other trials in France

Sweden1 site

  • Study site

    Huddinge, 14186

Other trials in Sweden

About this study

Official title: Non-Randomized, Multicenter Study to Evaluate the Pharmacokinetics and Safety of Peginterferon Alfa-2a and Copegus Combination Therapy After Single and Multiple Doses in Patients With Chronic Hepatitis C and Moderate Renal Impairment, Severe Renal Impairment, or End-Stage Renal Disease Undergoing Hemodialysis

This study will evaluate the pharmacokinetics (area under the curve [AUC], maximum concentration [Cmax], and other parameters) and tolerability of peginterferon alfa-2a and ribavirin combination therapy following single and multiple doses in participants with CHC infection and moderate to severe renal impairment or end-stage renal disease (ESRD) receiving hemodialysis. The anticipated time on study treatment is up to 48 weeks, and the target sample size is 48 individuals.

Being tested
Peginterferon alfa-2a, 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-2aDrug

    Also called Pegasys

    Peginterferon alfa-2a will be administered for 12 to 48 weeks. The dose will range from 135 mcg (Group C) to 180 mcg (Groups A, B, and D) once weekly via SC route.

  • RibavirinDrug

    Also called Copegus

    Ribavirin will be administered for 12 to 48 weeks. The total daily dosage will range from 200 mg (Group C) to 1200 mg (Group D), depending upon CrCl and participant-specific factors.

Study groups in NCT02864199
Study groupRoleWhat they receive
Group A: Moderate Renal ImpairmentExperimentalParticipants with CrCl 30 to 50 mL/min will receive 12 weeks of peginterferon alfa-2a, 180 micrograms (mcg) via subcutaneous (SC) injection once weekly, in combination with ribavirin, 600 milligrams (mg) orally (PO) daily in two divided doses. Those with Genotype 2 or 3 disease may receive an additional 12 weeks of the same regimen, and those with another genotype may receive an additional 36 weeks.
Receives: Drug: Peginterferon alfa-2a; Drug: Ribavirin
Group B: Severe Renal ImpairmentExperimentalParticipants with CrCl <30 mL/min will receive 12 weeks of peginterferon alfa-2a, 180 mcg via SC injection once weekly, in combination with ribavirin, 400 mg PO daily in two divided doses. Those with Genotype 2 or 3 disease may receive an additional 12 weeks of the same regimen, and those with another genotype may receive an additional 36 weeks.
Receives: Drug: Peginterferon alfa-2a; Drug: Ribavirin
Group C: Hemodialysis/ESRDExperimentalParticipants requiring hemodialysis will receive 12 weeks of peginterferon alfa-2a, 135 mcg via SC injection once weekly, in combination with ribavirin, 200 mg PO every morning. Those with Genotype 2 or 3 disease may receive an additional 12 weeks of the same regimen, and those with another genotype may receive an additional 36 weeks.
Receives: Drug: Peginterferon alfa-2a; Drug: Ribavirin
Group D: Normal Renal FunctionExperimentalParticipants with CrCl >80 mL/min will receive 12 weeks of peginterferon alfa-2a, 180 mcg via SC injection once weekly, in combination with ribavirin, 800 to 1200 mg PO daily in two divided doses. Those with Genotype 2 or 3 disease may receive an additional 12 weeks of the same regimen, and those with another genotype may receive an additional 36 weeks.
Receives: Drug: Peginterferon alfa-2a; Drug: Ribavirin

What is being measured

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

  1. Cmax of peginterferon alfa-2a

    Measured: Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12

  2. CL/F of ribavirin

    Measured: Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12

  3. Percentage of participants with undetectable HCV RNA level

    Measured: Week 12

  4. Cmax of ribavirin

    Measured: Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12

  5. AUC of ribavirin

    Measured: Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12

  6. AUC of peginterferon alfa-2a

    Measured: Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12

  7. Clearance (CL/F) of peginterferon alfa-2a

    Measured: Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12

Secondary outcomes (5)

  1. Time of maximum concentration (Tmax) of peginterferon alfa-2a

    Measured: Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12

  2. Tmax of ribavirin

    Measured: Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12

  3. Plasma concentration of ribavirin

    Measured: Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12

  4. Percentage of participants with adverse events (AEs)

    Measured: From Baseline to Week 12 (or up to Week 48 if treatment continued)

  5. Percentage of participants with a dose modification or premature withdrawal for safety reasons

    Measured: From Baseline to Week 12 (or up to Week 48 if treatment continued)

Timeline

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

  1. First posted11 Aug 2016 (estimated)
  2. Study startFeb 2004
  3. Primary completionSep 2007
  4. Study completionSep 2007

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
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02864199
Sponsor's protocol ID
NP17355
Status last verified
Aug 2016
First submitted
9 Aug 2016
Last updated
11 Aug 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Peginterferon alfa-2a and Ribavirin in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 17 sites in 5 countries.

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 8 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 11 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States, New Zealand, Brazil, France, Sweden. 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?

Cmax of peginterferon alfa-2a (time frame: Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12). The study lists 7 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 NCT02864199.

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 11 Aug 2016.

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