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Hepatitis C, ChronicNCT02850289

APPROACH Study: Quality of Life and Outcomes Assessment in Participants With Chronic Hepatitis C (CHC) Treated With Pegylated Interferon (PEG-IFN) Alfa-2a and Ribavirin

An observational study of Hepatitis C, Chronic, run by Hoffmann-La Roche at 46 sites in Canada.

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 multi-center, observational study will examine the clinical use and outcomes of pegylated interferon (PEG-IFN) alfa-2a and ribavirin combination (PEGASYS RBV) in participants with chronic hepatitis C (CHC). Study visits will be scheduled for baseline, 12, 24 and 48 weeks after baseline. 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 (PEG-INF) alfa-2a and Ribavirin
How many people
385 participants
Where
46 sitesCanada
Study dates
Apr 2006to Oct 2008
Phase
Observational
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Participants with hepatitis C, who were to be treated with combination of pegylated interferon (PEG-IFN) alfa-2a and ribavirin (PEGASYS RBV), within 7 days of baseline.

Who may be able to join

  • Eligible for and scheduled to receive treatment with commercially available PEG-IFN alfa-2a and ribavirin combination
  • Serologic evidence of chronic hepatitis C (CHC) infection
  • Detectable serum hepatitis C virus - ribonucleic acid (HCV-RNA)
  • Negative urine or blood pregnancy test
  • Fertile participants receiving treatment to use two forms of effective contraception during treatment and for 6 months after treatment end

Who cannot join

  • Women with ongoing pregnancy or who are breast feeding, or male partners of women who are pregnant
  • Received any investigational drug less than or equal to (</=) 6 weeks prior to enrollment
  • Moderate hepatic failure [Child-Pugh greater than or equal to (>/=) B]
  • Co-infection with human immunodeficiency virus (HIV) or hepatitis B
  • Autoimmune hepatitis
  • Known hypersensitivity to alfa interferons, E. coli-derived products, polyethylene glycol, ribavirin and/or any ingredient in the formulation or component of PEG-IFN alfa-2a or ribavirin

Trial locations and contacts

46 sites in 1 country.

46 sites in 1 country

Canada46 sites

  • Study site

    Abbotsford British Columbia, British Columbia, V2S 3N5

  • Study site

    Barrie, Ontario, L4M 5G1

  • Study site

    Brampton, Ontario, L6V 1B4

  • Study site

    Calgary, Alberta, T2N 4N1

  • Study site

    Downsview, Ontario, M3N 2V7

  • Study site

    Edmonton, Alberta, T5H 4B9

  • Study site

    Edmonton, Alberta, T6G 2C8

  • Study site

    Edmonton, Alberta, T6G2B7

  • Study site

    Greater Sudbury, Ontario, P3E 1B8

  • Study site

    Hamilton, Ontario, L8L 2X2

  • Study site

    Kingston, Ontario, K7L 5G2

  • Study site

    London, Ontario, N6A 5A5

  • Study site

    London, Ontario, N6A 5R9

  • Study site

    London, Ontario, N6B 2L4

  • Study site

    Mississauga, Ontario, L5M 2V8

  • Study site

    Montreal, Quebec, H1T 2M4

  • Study site

    Montreal, Quebec, H3A 1A1

  • Study site

    Montreal, Quebec, H4J 1C5

  • Study site

    Montreal, Quebec, J2X 4S7

  • Study site

    Newmarket, Ontario, L3Y 2P6

  • Study site

    Oshawa, Ontario, L1G 2B9

  • Study site

    Oshawa, Ontario, L1J 2J9

  • Study site

    Ottawa, Ontario, K1H 8L6

  • Study site

    Ottawa, Ontario, K1Y 4E9

  • Study site

    Québec, Quebec, G1L 3L5

  • Study site

    Québec, Quebec, G1R 1S9

  • Study site

    Québec, Quebec, G1R 2J6

  • Study site

    Québec, Quebec, QC G1S 4L8

  • Study site

    Regina, Saskatchewan, S4P 4V6

  • Study site

    Richmond Hill, Ontario, L4E 4L6

  • Study site

    Richmond Hill, Ontario

  • Study site

    Saint-Charles-Borromée, Quebec, J6E 2C3

  • Study site

    Saskatoon, Saskatchewan, S7N 0W8

  • Study site

    Surrey, British Columbia, V3V 1Z1

  • Study site

    Thunder Bay, Ontario, P7B 6V4

  • Study site

    Toronto, Ontario, M5G 2C4

  • Study site

    Toronto, Ontario, M6H 3M1

  • Study site

    Vancouver, British Columbia, V5Z 1H2

  • Study site

    Vancouver, British Columbia, V5Z 3P1

  • Study site

    Vancouver, British Columbia, V6Z 2C7

  • Study site

    Vancouver, British Columbia, V6Z 2K5

  • Study site

    Vernon, British Columbia, V1T 1W9

  • Study site

    West Vancouver, British Columbia, V7S 1X1

  • Study site

    Windsor, Ontario, N8X 5A6

  • Study site

    Windsor, Ontario, N9A 1C9

  • Study site

    Winnipeg, Manitoba, R2W 5L4

Other trials in Canada

About this study

Official title: A Prospective Study of Peginterferon Alfa-2a and Ribavirin: Outcomes Assessment in Chronic Hepatitis C Patients

This multi-center, observational study will examine the clinical use and outcomes of pegylated interferon (PEG-IFN) alfa-2a and ribavirin combination (PEGASYS RBV) in participants with chronic hepatitis C (CHC). Study visits will be scheduled for baseline, 12, 24 and 48 weeks after baseline. An additional follow-up visit at week 72 will be required for participants with an HCV genotype other than 2 or 3. Quality of life data will be collected at baseline, and at each follow-up visit.

Being tested
Pegylated interferon (PEG-INF) 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 (PEG-INF) alfa-2aDrug

    Also called PEGASYS

    Pegylated interferon (PEG-IFN) alfa-2a will be administered as per investigator's discretion and will be in line with the current product monograph.

  • RibavirinDrug

    Also called COPEGUS

    Ribavirin will be administered as per investigator's discretion and will be in line with the current product monograph.

Study groups in NCT02850289
Study groupRoleWhat they receive
Pegylated Interferon (PEG-IFN) alfa-2a and RibavirinParticipants with hepatitis C who were to be treated with combination of pegylated interferon (PEG-IFN) alfa-2a and ribavirin, within 7 days of baseline, with ongoing management at investigator's discretion.
Receives: Drug: Pegylated interferon (PEG-INF) 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 Virologic Response (SVR)

    Measured: Up to Week 72

Secondary outcomes (4)

  1. Short Form Health Survey (SF-36) Physical Composite Score

    Measured: Baseline, Week 12, 24, 48 and 72

  2. Short Form Health Survey (SF-36) Mental Composite Score

    Measured: Baseline, Week 12, 24, 48 and 72

  3. Percentage of Participants with Adverse Events of Special Interest Leading to Study Medication Discontinuation

    Measured: Up to Week 72

  4. Percentage of Participants Who Utilized Resources

    Measured: Baseline, Week 12, 24, 48 and 72

Timeline

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

  1. First posted29 Jul 2016 (estimated)
  2. Study startApr 2006
  3. Primary completionOct 2008
  4. Study completionOct 2008

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
385 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02850289
Sponsor's protocol ID
ML20090
Status last verified
Oct 2017
First submitted
28 Jul 2016
Last updated
3 Oct 2017
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatitis C, Chronic, run by Hoffmann-La Roche at 46 sites in Canada.

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 6 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 3 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in Canada. 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?

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?

Percentage of Participants with Sustained Virologic Response (SVR) (time frame: Up to Week 72). 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 NCT02850289.

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 3 Oct 2017.

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