Hepatitis D, ChronicPhase 3NCT01088659
A Study of Pegasys (Peginterferon Alfa 2a) Alone or in Combination With Tenofovir in Patients With Chronic Hepatitis D.
A Phase 3 study testing peginterferon alfa-2a [Pegasys] and tenofovir in people with Hepatitis D, Chronic, run by Hoffmann-La Roche at 6 sites in Turkey (Türkiye).
Trial summary
This randomized, single blind study will compare the antiviral effect of Pegasys (pegylated interferon alfa-2a) plus placebo versus Pegasys plus tenofovir in patients with chronic hepatitis D. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis D, Chronic
- What is being tested?
- peginterferon alfa-2a [Pegasys] and tenofovir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 6 sitesTurkey (Türkiye)
- Study dates
- 16 Feb 2010to 29 Dec 2017
- Phase
- Phase 3
- 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
Who may be able to join
- adult patients, >/=18 years of age
- chronic hepatitis D
- positive for HBsAg >/=6 months, for anti-HDV >/=3 months and for HDV-RNA at screening
- negative pregnancy test; fertile males and women of childbearing age should use two reliable forms of contraception throughout study
Who cannot join
- antiviral therapy for chronic hepatitis D within the previous 6 months
- previous therapy with pegylated interferon alfa
- treatment with conventional interferon alfa for >12 months
- hepatitis A or C, or HIV infection
- decompensated liver disease (Childs B-C)
- history or evidence of medical condition associated with chronic liver disease
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Turkey (Türkiye)6 sites
Ankara University Medical Facility; Hepatology Department
Ankara, 06620
Uni of Uludag Faculty of Medicine; I, Hastaliklari Anabilim Dali
Bursa, 16059
Dicle Uni Medical Faculty; Gastroenterology
Diyarbakır, 10000
Istanbul Uni Cerrahpasa Medical Faculty; Gastroenterolgy
Istanbul, 34390
Ege Uni Medical Faculty Izmir; Gastroenterology
Izmir, 35100
Dokuz Eylul University Medical Faculty; Infection
Izmir, 35340
About this study
Official title: A Multicenter Randomised Study Comparing the Antiviral Efficacy of Pegylated Interferon-alfa-2a Plus Placebo vs. Pegylated Interferon-alfa-2a Plus Tenofovir for the Treatment of Chronic Delta Hepatitis
This randomized, single blind study will compare the antiviral effect of Pegasys (pegylated interferon alfa-2a) plus placebo versus Pegasys plus tenofovir in patients with chronic hepatitis D. Patients will be randomized to receive 96 weeks of therapy with Pegasys (180 micrograms sc weekly) plus either placebo (orally daily) or tenofovir (245mg orally daily). Anticipated time on study treatment is 2+ years, target sample size is <50.
- Conditions
- Hepatitis D, Chronic
- Being tested
- peginterferon alfa-2a [Pegasys], placebo, tenofovir
- Medical subject headings
- Hepatitis D, 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
180mcg sc weekly, 96 weeks
placeboDrug
orally daily, 96 weeks
tenofovirDrug
245mg po daily, 96 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: peginterferon alfa-2a [Pegasys]; Drug: placebo |
| 2 | Experimental | Not described Receives: Drug: peginterferon alfa-2a [Pegasys]; Drug: tenofovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of patients becoming HDV-RNA negative
Measured: week 96
Secondary outcomes (2)
HDV-RNA levels, HBsAg levels, HBV DNA, biochemical disease activity, liver histology
Measured: weeks 48, 96 and after 24 weeks of follow-up
Safety and tolerability: adverse events, laboratory parameters, vital signs
Measured: throughout 96 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2010 (estimated)
- Study start16 Feb 2010
- Primary completion29 Dec 2017
- Study completion29 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis D, ChronicStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01088659
- Sponsor's protocol ID
- ML22364
- Status last verified
- Jan 2019
- First submitted
- 16 Mar 2010
- Last updated
- 14 Jan 2019
- Results posted
- No
Publications
Wedemeyer H, Yurdaydin C, Hardtke S, Caruntu FA, Curescu MG, Yalcin K, Akarca US, Gurel S, Zeuzem S, Erhardt A, Luth S, Papatheodoridis GV, Keskin O, Port K, Radu M, Celen MK, Idilman R, Weber K, Stift J, Wittkop U, Heidrich B, Mederacke I, von der Leyen H, Dienes HP, Cornberg M, Koch A, Manns MP; HIDIT-II study team. Peginterferon alfa-2a plus tenofovir disoproxil fumarate for hepatitis D (HIDIT-II): a randomised, placebo controlled, phase 2 trial. Lancet Infect Dis. 2019 Mar;19(3):275-286. doi: 10.1016/S1473-3099(18)30663-7.
PubMed 30833068
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomised Study Comparing the Antiviral Efficacy of Pegylated Interferon-alfa-2a Plus Placebo vs. Pegylated Interferon-alfa-2a Plus Tenofovir for the Treatment of Chronic Delta Hepatitis
- ClinicalTrials.gov ID
- NCT01088659
- Acronym / sponsor ID
- ML22364
- Conditions
- Hepatitis D, Chronic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 16 Feb 2010 (actual)
- Primary completion
- 29 Dec 2017 (actual)
- Study completion
- 29 Dec 2017 (actual)
- First posted
- 17 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized, single blind study will compare the antiviral effect of Pegasys (pegylated interferon alfa-2a) plus placebo versus Pegasys plus tenofovir in patients with chronic hepatitis D. Patients will be randomized to receive 96 weeks of therapy with Pegasys (180 micrograms sc weekly) plus either placebo (orally daily) or tenofovir (245mg orally daily). Anticipated time on study treatment is 2+ years, target sample size is <50.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: peginterferon alfa-2a [Pegasys], Drug: placebo |
| 2 | Experimental | Drug: peginterferon alfa-2a [Pegasys], Drug: tenofovir |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adult patients, >/=18 years of age
- chronic hepatitis D
- positive for HBsAg >/=6 months, for anti-HDV >/=3 months and for HDV-RNA at screening
- negative pregnancy test; fertile males and women of childbearing age should use two reliable forms of contraception throughout study
Key exclusion criteria (6 listed)
- antiviral therapy for chronic hepatitis D within the previous 6 months
- previous therapy with pegylated interferon alfa
- treatment with conventional interferon alfa for >12 months
- hepatitis A or C, or HIV infection
- decompensated liver disease (Childs B-C)
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 |
|---|---|---|
| peginterferon alfa-2a [Pegasys]180mcg sc weekly, 96 weeks | Drug | 1, 2 |
| placeboorally daily, 96 weeks | Drug | 1 |
| tenofovir245mg po daily, 96 weeks | Drug | 2 |
Primary outcome
proportion of patients becoming HDV-RNA negative
Time frame: week 96
2 secondary outcomes
HDV-RNA levels, HBsAg levels, HBV DNA, biochemical disease activity, liver histology
Time frame: weeks 48, 96 and after 24 weeks of follow-up
Safety and tolerability: adverse events, laboratory parameters, vital signs
Time frame: throughout 96 weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2019.
- Derived from this study: PubMed 30833068Wedemeyer H, Yurdaydin C, Hardtke S, Caruntu FA, Curescu MG, Yalcin K, Akarca US, Gurel S, Zeuzem S, Erhardt A, Luth S, Papatheodoridis GV, Keskin O, Port K, Radu M, Celen MK, Idilman R, Weber K, Stift J, Wittkop U, Heidrich B, Mederacke I, von der Leyen H, Dienes HP, Cornberg M, Koch A, Manns MP; HIDIT-II study team. Peginterferon alfa-2a plus tenofovir disoproxil fumarate for hepatitis D (HIDIT-II): a randomised, placebo controlled, phase 2 trial. Lancet Infect Dis. 2019 Mar;19(3):275-286. doi: 10.1016/S1473-3099(18)30663-7.
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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.
Clinical Trials study director
Hoffmann-La Roche
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing peginterferon alfa-2a [Pegasys] and tenofovir in people with Hepatitis D, Chronic, run by Hoffmann-La Roche at 6 sites in Turkey (Türkiye).
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 4 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 14 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Turkey (Türkiye). 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?
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?
proportion of patients becoming HDV-RNA negative (time frame: week 96). 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 NCT01088659, 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 14 Jan 2019.