Hepatitis C, ChronicPhase 4ACTIVATENCT01364090
A Collaborative Trial in Injectors of Individualized Treatment for Genotype 2/3
A Phase 4 study testing Pegylated interferon alfa 2b and Ribavirin in people with Hepatitis C, Chronic, run by Kirby Institute at 17 sites in 7 countries.
Trial summary
This sudy will determine whether shortening treatment for hepatitis C is feasible, safe and effective for patients who are current injection drug users or receiving opiate substitution therapy and who are responding well to treatment early on. 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 2b and Ribavirin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 17 sitesin 7 countries
- Study dates
- Jun 2012to Oct 2015
- 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
- 18 years of age
- chronic HCV infection
- HCV genotype 2/3 infection
- active injection drug use (within 24 weeks prior to consent) or currently receiving opiate substitution therapy
- compensated liver disease
- negative pregnancy test (within 24 hours of first dose of study medication)
- effective contraception for the duration of the study
- written informed consent
Who cannot join
- previous interferon or ribavirin therapy
- investigation drug use in the 6 weeks prior to first dose of study medication
- infection with HCV genotypes other than 2/3
- HIV infection
- HBV infection
- ongoing severe psychiatric disease
- frequent drug use that is judged by the treating physician to compromise treatment safety
- standard clinical and medical exclusions for treatment with pegylated interferon alfa 2b and ribavirin
Trial locations and contacts
17 sites in 7 countries.
17 sites in 7 countries
Australia5 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Alfred Hospital
Melbourne, Victoria, 3004
Hunter Pharmacotherapy
Newcastle, New South Wales, 2300
Nepean Hospital
Penrith, New South Wales, 2751
St Vincent's Hospital
Sydney, New South Wales, 2010
Canada3 sites
CHUM - Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X 1P1
East Toronto Hepatitis C Program
Toronto, Ontario, M4M 3P3
Vancouver ID Research and Care Centre Society
Vancouver, British Columbia, V6Z2C7
Switzerland3 sites
Basel Zentrum fur Suchtmedizin
Basel, 4057
Koda Bern/Poliklinik fur Infektiologe
Bern, 3010
ARUD, Poliklinik Zokl 1
Zurich, CH-8005
Belgium2 sites
ZNA Stuivenberg / MSOC Free Clinic
Antwerp
Ziekenhuis Oost Limburg / MSOC Limburg
Genk
United Kingdom2 sites
East London Foundation NHS Trust
London, E1 4DG
Nottingham University Hospitals NHS Trust
Nottingham, NG5 1PB
About this study
Official title: A Phase IV, Open-label, Multicentre, International Trial of Response Guided Treatment With Directly Observed Pegylated Interferon Alfa 2b (PEG-IFN-alfa 2b) and Self Administered Ribavirin (RBV) for Patients With Chronic HCV Genotype 2 or 3 and Injection Drug Use
This sudy will determine whether shortening treatment for hepatitis C is feasible, safe and effective for patients who are current injection drug users or receiving opiate substitution therapy and who are responding well to treatment early on.
Read the detailed description
The study will evaluate the feasibility, safety and effectiveness of shortened treatment for hepatitis C genotypes 2/3 in current injection drug users or receiving opiate substitution therapy. Treatment will be with pegylated interferon alfa 2b (directly observed) and ribavirin for 12 weeks in those that have non-quantifiable (<15 IU/ml detected and <15 IU/ml undetected) HCV RNA or undetectable HCV RNA on qualitative assay at week 4 and 24 weeks in those that have quantifiable (≥15 IU/ml) HCV RNA or detectable HCV RNA on qualitative assay at week 4.
- Conditions
- Hepatitis C, Chronic
- Being tested
- Pegylated interferon alfa 2b, Ribavirin
- Keywords
- hepatitis C, treatment, injection drug users or receiving opiate substitution therapy
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegylated interferon alfa 2bDrug
Also called PegInteron
Pegylated interferon alfa 2b 1.5 mcg/kg/week to a maximum of 150 mcg/week administered subcutaneously once weekly directly observed.
RibavirinDrug
Ribavirin - 800-1400 mg daily according to weight taken orally with food, self administered in split doses.
| Study group | Role | What they receive |
|---|---|---|
| Standard Treatment Duration (24 weeks) | Active comparator | Subjects with detectable HCV RNA after four weeks of therapy will continue on PEG-IFN and ribavirin until week 24 and follow-up for an additional 24 weeks following treatment completion (48 weeks in total). Receives: Drug: Pegylated interferon alfa 2b; Drug: Ribavirin |
| Shortened Treatment Duration (12 Weeks) | Experimental | Subjects with undetectable HCV RNA after four weeks of therapy will continue on PEG-IFN and ribavirin until week 12 and follow-up for an additional 24 weeks following treatment completion (36 weeks in total). Receives: Drug: Pegylated interferon alfa 2b; Drug: Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Efficacy
The primary outcome measure is the number of patients with undetectable HCV RNA at 12 weeks post end of treatment (SVR12) following directly observed PEG-IFN alfa-2b in combination with self-administered ribavirin for 12 weeks in participants with non-quantifiable (<15 IU/ml detected and <15 IU/ml undetected) HCV RNA or undetectable HCV RNA on qualitative assay at week 4 of therapy and for 24 weeks in participants with quantifiable (≥15 IU/ml) HCV RNA or detectable HCV RNA on qualitative assay at week 4 of therapy.
Measured: 36 weeks
Secondary outcomes (3)
Treatment Adherence
Evaluate the adherence (>80 of PEG-IFN, >80% of RBV, >80% of time) to directly observed PEG-IFN alfa-2b in combination with self-administered ribavirin for 12 weeks in participants with non-quantifiable HCV RNA or undetectable HCV RNA on qualitative assay at week 4 of therapy and for 24 weeks in participants with quantifiable HCV RNA or detectable HCV RNA on qualitative assay at week 4 of therapy.
Measured: 48 weeks
Treatment Response (ETR & SVR24)
Evaluate the percentage with undetectable HCV RNA at end of treatment (ETR) and 24 weeks post end of treatment (SVR24) in participants treated with PEG-IFN alfa-2b in combination with self-administered ribavirin for 12 weeks in participants with non quantifiable HCV RNA or undetectable HCV RNA at week 4 of therapy and for 24 weeks in participants with quantifiable HCV RNA or detectable HCV RNA at week 4 of therapy.
Measured: 48 weeks
Behavioral and Quality of Life
Evaluate changes in illicit drug use, opiate substitution therapy, depression, suicidal ideations and health-related quality of life in participants treated with PEG-IFN alfa-2b in combination with self-administered ribavirin for 12 weeks in participants with non-quantifiable HCV RNA or undetectable HCV RNA on qualitative assay at week 4 of therapy and for 24 weeks in participants with quantifiable HCV RNA or detectable HCV RNA at week 4 of therapy.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2011 (estimated)
- Study startJun 2012
- Primary completionJun 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirby Institute
- Sponsor type
- Other government
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Gregory Dore, MBBS, PhD, Study chair, University of New South WalesOlav Dalgard, MD PhD, Study chair, University Hospital, Akershus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01364090
- Sponsor's protocol ID
- VHCRP1007
- Acronym
- ACTIVATE
- Status last verified
- Nov 2019
- First submitted
- 31 May 2011
- Last updated
- 18 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Cunningham EB, Hajarizadeh B, Dalgard O, Amin J, Hellard M, Foster GR, Bruggmann P, Conway B, Backmund M, Robaeys G, Swan T, Marks PS, Quiene S, Applegate TL, Weltman M, Shaw D, Dunlop A, Bruneau J, Midgard H, Bourgeois S, Thurnheer MC, Dore GJ, Grebely J; ACTIVATE Study Group. Adherence to response-guided pegylated interferon and ribavirin for people who inject drugs with hepatitis C virus genotype 2/3 infection: the ACTIVATE study. BMC Infect Dis. 2017 Jun 13;17(1):420. doi: 10.1186/s12879-017-2517-3.
PubMed 28610605
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Open-label, Multicentre, International Trial of Response Guided Treatment With Directly Observed Pegylated Interferon Alfa 2b (PEG-IFN-alfa 2b) and Self Administered Ribavirin (RBV) for Patients With Chronic HCV Genotype 2 or 3 and Injection Drug Use
- ClinicalTrials.gov ID
- NCT01364090
- Acronym / sponsor ID
- ACTIVATE / VHCRP1007
- Conditions
- Hepatitis C, Chronic
- Keywords
- hepatitis C, treatment, injection drug users or receiving opiate substitution therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Kirby InstituteOther government
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jun 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 2 Jun 2011 (estimated)
- Results
- Posted 18 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This sudy will determine whether shortening treatment for hepatitis C is feasible, safe and effective for patients who are current injection drug users or receiving opiate substitution therapy and who are responding well to treatment early on.
Detailed description
The study will evaluate the feasibility, safety and effectiveness of shortened treatment for hepatitis C genotypes 2/3 in current injection drug users or receiving opiate substitution therapy. Treatment will be with pegylated interferon alfa 2b (directly observed) and ribavirin for 12 weeks in those that have non-quantifiable (<15 IU/ml detected and <15 IU/ml undetected) HCV RNA or undetectable HCV RNA on qualitative assay at week 4 and 24 weeks in those that have quantifiable (≥15 IU/ml) HCV RNA or detectable HCV RNA on qualitative assay at week 4.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Treatment Duration (24 weeks) | Active comparator | Drug: Pegylated interferon alfa 2b, Drug: RibavirinSubjects with detectable HCV RNA after four weeks of therapy will continue on PEG-IFN and ribavirin until week 24 and follow-up for an additional 24 weeks following treatment completion (48 weeks in total). |
| Shortened Treatment Duration (12 Weeks) | Experimental | Drug: Pegylated interferon alfa 2b, Drug: RibavirinSubjects with undetectable HCV RNA after four weeks of therapy will continue on PEG-IFN and ribavirin until week 12 and follow-up for an additional 24 weeks following treatment completion (36 weeks in total). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years of age
- chronic HCV infection
- HCV genotype 2/3 infection
- active injection drug use (within 24 weeks prior to consent) or currently receiving opiate substitution therapy
- compensated liver disease
Key exclusion criteria (8 listed)
- previous interferon or ribavirin therapy
- investigation drug use in the 6 weeks prior to first dose of study medication
- infection with HCV genotypes other than 2/3
- HIV infection
- HBV infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pegylated interferon alfa 2bAlso: PegInteronPegylated interferon alfa 2b 1.5 mcg/kg/week to a maximum of 150 mcg/week administered subcutaneously once weekly directly observed. | Drug | Shortened Treatment Duration (12 Weeks), Standard Treatment Duration (24 weeks) |
| RibavirinRibavirin - 800-1400 mg daily according to weight taken orally with food, self administered in split doses. | Drug | Shortened Treatment Duration (12 Weeks), Standard Treatment Duration (24 weeks) |
Primary outcome
Treatment Efficacy
Time frame: 36 weeks
The primary outcome measure is the number of patients with undetectable HCV RNA at 12 weeks post end of treatment (SVR12) following directly observed PEG-IFN alfa-2b in combination with self-administered ribavirin for 12 weeks in participants with non-quantifiable (<15 IU/ml detected and <15 IU/ml undetected) HCV RNA or undetectable HCV RNA on qualitative assay at week 4 of therapy and for 24 weeks in participants with quantifiable (≥15 IU/ml) HCV RNA or detectable HCV RNA on qualitative assay at week 4 of therapy.
3 secondary outcomes
Treatment Adherence
Time frame: 48 weeks
Treatment Response (ETR & SVR24)
Time frame: 48 weeks
Behavioral and Quality of Life
Time frame: 48 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28610605Cunningham EB, Hajarizadeh B, Dalgard O, Amin J, Hellard M, Foster GR, Bruggmann P, Conway B, Backmund M, Robaeys G, Swan T, Marks PS, Quiene S, Applegate TL, Weltman M, Shaw D, Dunlop A, Bruneau J, Midgard H, Bourgeois S, Thurnheer MC, Dore GJ, Grebely J; ACTIVATE Study Group. Adherence to response-guided pegylated interferon and ribavirin for people who inject drugs with hepatitis C virus genotype 2/3 infection: the ACTIVATE study. BMC Infect Dis. 2017 Jun 13;17(1):420. doi: 10.1186/s12879-017-2517-3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory Dore, MBBS, PhD study chair
University of New South Wales
Olav Dalgard, MD PhD study chair
University Hospital, Akershus
17 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pegylated interferon alfa 2b and Ribavirin in people with Hepatitis C, Chronic, run by Kirby Institute at 17 sites in 7 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 8 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 18 Nov 2019. 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 Australia, Canada, Switzerland, Belgium, United Kingdom and 2 more countries. 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 18 Oct 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?
Treatment Efficacy (time frame: 36 weeks). 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 NCT01364090, 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 18 Nov 2019.