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Hepatitis C, ChronicPhase 3IMPROVENCT00483938

The Individualized Management With Pegylated-interferon Alfa-2a (Pegasys) and Ribavirin (Copegus) Offering Viral Eradication: A Study of Pegylated-interferon Alfa-2a Plus Ribavirin in Participants With Chronic Hepatitis C (CHC) Non-genotype 2/3 (IMPROVE)

A Phase 3 study testing Pegylated-interferon Alfa-2a and Ribavirin in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 23 sites in 2 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 compare the efficacy and safety of treatment with pegylated-interferon alfa-2a plus ribavirin in participants with non-genotype 2/3 CHC who, after 12 weeks of study treatment, have undetectable hepatitis C virus (HCV)-ribonucleic acid (RNA) or a greater than or equal to (>=) 2 log10 drop in HCV-RNA. 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?
Pegylated-interferon Alfa-2a and Ribavirin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
236 participants
Where
23 sitesin 2 countries
Study dates
Jun 2007to May 2010
Phase
Phase 3
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

  • evidence of CHC;
  • evidence of hepatitis C non-genotype 2 or 3;
  • compensated liver disease.

Who cannot join

  • infection with HCV genotype 2 or 3;
  • history of having received systemic antiviral therapy with activity against CHC <=3 months prior to start of study;
  • hepatitis A, hepatitis B or human immunodeficiency virus (HIV) infection;
  • history or evidence of a medical condition associated with chronic liver disease other than CHC.

Trial locations and contacts

23 sites in 2 countries.

23 sites in 2 countries

Canada22 sites

  • Study site

    Abbotsford British Columbia, British Columbia, V2S 3N5

  • Study site

    Calgary, Alberta, T2N 4Z6

  • Study site

    East York, Ontario, M4C 3E7

  • Study site

    Edmonton, Alberta, T5H 4B9

  • Study site

    Edmonton, Alberta, T6G 2X8

  • Study site

    Halifax, Nova Scotia, B3H 2Y9

  • Study site

    Hamilton, Ontario, L8L 2X2

  • Study site

    Kingston, Ontario, K7L 5G2

  • Study site

    London, Ontario, N6A 5A5

  • Study site

    Mississauga, Ontario, L5M 4N4

  • Study site

    Montreal, Quebec, H1T 2M4

  • Study site

    Montreal, Quebec, H3A 1A1

  • Study site

    Ottawa, Ontario, K1H 8L6

  • Study site

    Saskatoon, Saskatchewan, S7N 0W8

  • Study site

    Toronto, Ontario, M5G 1L7

  • Study site

    Toronto, Ontario, M5G 1X5

  • Study site

    Toronto, Ontario, M6H 3M1

  • Study site

    Vancouver, British Columbia, V5Z 1M9

  • Study site

    Vancouver, British Columbia, V6Z 2K5

  • Study site

    Vernon, British Columbia, V1T 1W9

  • Study site

    Victoria, British Columbia, V8V 3P9

  • Study site

    Woodbridge, Ontario, L4L 4Y7

Other trials in Canada

United States1 site

  • Study site

    Milwaukee, Wisconsin, 53210

Other trials in United States

About this study

Official title: The Individualized Management With Pegasys and Ribavirin Offering Viral Eradication (IMPROVE) Trial

This study will compare the efficacy and safety of treatment with pegylated-interferon alfa-2a plus ribavirin in participants with non-genotype 2/3 CHC who, after 12 weeks of study treatment, have undetectable hepatitis C virus (HCV)-ribonucleic acid (RNA) or a greater than or equal to (>=) 2 log10 drop in HCV-RNA. Participants will be randomized to receive pegylated-interferon alfa-2a 180 micrograms subcutaneously weekly plus ribavirin (1000-1400 milligram [mg]) orally daily for the specified duration, followed by 24 weeks of treatment-free follow-up. Participants with detectable HCV-RNA and less than (<) 2 log10 drop in HCV-RNA at week 12 will discontinue therapy.

Being tested
Pegylated-interferon 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.

  • Pegylated-interferon Alfa-2aDrug

    Also called Pegasys

    Participants will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for the specified duration.

  • RibavirinDrug

    Also called Copegus

    Participants will receive ribavirin 1000 to 1400 mg orally daily for the specified duration.

Study groups in NCT00483938
Study groupRoleWhat they receive
Pegylated-interferon Alfa-2a + Ribavirin (Group A)ExperimentalParticipants with HCV RNA levels greater than (>) 15 international units per milliliter (IU/mL) at Week 4, HCV RNA greater than or equal to (>=) 15 IU/mL at Week 8, and either HCV RNA less than (<) 15 IU/mL or >=2 times logarithmic (2 log10) drop at Week 12, will receive pegylated-interferon alfa-2a (Pegasys) 180 micrograms (mcg) subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 milligrams (mg) orally daily for 48 weeks.
Receives: Drug: Pegylated-interferon Alfa-2a; Drug: Ribavirin
Pegylated-interferon Alfa-2a + Ribavirin (Group B)ExperimentalParticipants with HCV RNA levels >15 IU/mL at Week 4, HCV RNA >=15 IU/mL at Week 8, and either HCV RNA <15 IU/mL or >=2 log10 drop at Week 12, will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 72 weeks, and ribavirin 1000 to 1400 mg orally daily for 72 weeks.
Receives: Drug: Pegylated-interferon Alfa-2a; Drug: Ribavirin
Pegylated-interferon Alfa-2a + Ribavirin (Group C)ExperimentalParticipants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 36 weeks, and ribavirin 1000 to 1400 mg orally daily for 36 weeks.
Receives: Drug: Pegylated-interferon Alfa-2a; Drug: Ribavirin
Pegylated-interferon Alfa-2a + Ribavirin (Group D)ExperimentalParticipants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
Receives: Drug: Pegylated-interferon Alfa-2a; Drug: Ribavirin
Pegylated-interferon Alfa-2a + Ribavirin (Group E)ExperimentalParticipants with HCV-RNA levels <15 IU/mL at Week 4, will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 24 weeks, and ribavirin 1000 to 1400 mg orally daily for 24 weeks.
Receives: Drug: Pegylated-interferon Alfa-2a; Drug: Ribavirin
Pegylated-interferon Alfa-2a + Ribavirin (Group F)ExperimentalParticipants with HCV-RNA levels <15 IU/mL at Week 4, will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
Receives: Drug: Pegylated-interferon Alfa-2a; Drug: Ribavirin
Pegylated-interferon Alfa-2a + Ribavirin (Group NR)ExperimentalParticipants who do not have any change in HCV-RNA levels at Weeks 4, 8, and 12 will not be randomized (NR) to any of the other groups. Participants will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
Receives: Drug: Pegylated-interferon Alfa-2a; Drug: Ribavirin

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 (SVR) (Groups A and B)

    SVR was defined as success if the participant had HCV RNA levels <15 IU/mL as measured by COBAS AmpliPrep/COBAS TaqMan® HCV test at the 24-week untreated follow-up visit (HCV-RNA levels obtained at least 18 weeks after last dose of either pegylated-Interferon alfa-2a or ribavirin were considered if the 24-week untreated follow-up visit data were missing). Percentage of participants with SVR for Groups A and B was reported in this analysis.

    Measured: At 24-week untreated follow-up visit (up to 72 weeks for Group A, up to 96 weeks for Group B)

Secondary outcomes (2)

  1. Percentage of Participants With SVR (Groups C, D, E, and F)

    SVR was defined as success if the participant had HCV RNA levels <15 IU/mL as measured by COBAS AmpliPrep/COBAS TaqMan® HCV test at the 24-week untreated follow-up visit (HCV-RNA levels obtained at least 18 weeks after last dose of either pegylated-Interferon alfa-2a or ribavirin were considered if the 24-week untreated follow-up visit data were missing). Percentage of participants with SVR for Groups C, D, E, and F was reported in this analysis.

    Measured: At 24-week untreated follow-up visit (up to 60, 72, 48, and 72 weeks for Groups C, D, E, and F, respectively)

  2. Percentage of Participants With Virological Responses (Groups A, B, C, D, E, and F)

    End of treatment response (ETR) was defined as "Success" if the HCV-RNA levels were <15 IU/mL at the end of treatment. Early virological response (EVR) was defined as >=2 log10 decrease in serum HCV RNA or undetectable serum HCV RNA (<15 IU/mL) at Week 12. Complete EVR was defined as "Success", if the HCV-RNA levels were <15 IU/mL at Week 12. Partial EVR was defined as "Success", if there was a >=2 log10 drop in HCV-RNA at Week 12 compared to baseline but with a level that was still >=15 IU/mL at that time point.

    Measured: Week 12 (Groups C, D, E, and F), and end of treatment (Weeks 48, 72, 36, 48, 24, and 48 for Groups A, B, C, D, E, and F, respectively)

Timeline

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

  1. First posted8 Jun 2007 (estimated)
  2. Study startJun 2007
  3. Primary completionMay 2010
  4. Study completionMay 2010

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
236 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00483938
Sponsor's protocol ID
ML21035
Acronym
IMPROVE
Status last verified
Nov 2016
First submitted
7 Jun 2007
Last updated
23 Jan 2017

Publications

  • Lee SS, Sherman M, Ramji A, Greenbloom S, Elkashab M, Pluta H, Hilzenrat N, Balshaw R, Usaty C, Myers RP. Randomised clinical trial: the efficacy of treatment, guided by a shorter duration of response, using peginterferon alfa-2a plus ribavirin for hepatitis C virus other than genotypes 2 or 3. Aliment Pharmacol Ther. 2012 Jan;35(1):37-47. doi: 10.1111/j.1365-2036.2011.04911.x. Epub 2011 Nov 2.

    PubMed 22050141

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pegylated-interferon Alfa-2a and Ribavirin in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 23 sites in 2 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 3 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 23 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in Canada, 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 23 Jan 2017). 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 (SVR) (Groups A and B) (time frame: At 24-week untreated follow-up visit (up to 72 weeks for Group A, up to 96 weeks for Group B)). 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 NCT00483938, 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 23 Jan 2017.

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