Chronic Hepatitis CPhase 4AddwinNCT01439776
Add Vitamin D With Standard of Care for Chronic Hepatitis C Patients
A Phase 4 study testing Vit D in people with Chronic Hepatitis C, run by Hanyang University at 13 sites in South Korea.
Trial summary
Standard therapy for chronic hepatitis C virus (HCV) is (Peg/RBV) combination therapy obtaining sustained virologic response (SVR) in 77% of naïve patients with genotype 1-3 Studies rarely address the issues of improving host factors. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- Vit D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 13 sitesSouth Korea
- Study dates
- Sep 2011to 20 Jan 2018
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic genotype 1-3 HCV infection
- Treatment Naive
Who cannot join
- Child B and C
- HCC patients
- Pregnancy
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
South Korea13 sites
Soonchunhyang university hospital Bucheon
Bucheon-si, Gyeonggi-do, 420767
Soonchunhyang university Hospital Cheonan
Cheonan, Chungcheongnam-do, 330721
Chuncheon Sacred Heart Hospital
Chuncheon, Kangwondo, 200704
HANYANG University Guri Hospital
Guri-si, Gyeonggido, 471701
Bundang Jesaeng Hospital
Seongnam, Gyeonggido, 463774
Kyong Hee University Medical Center
Seoul, 130702
Hanyang University Seoul Hospital
Seoul, 133792
Kangdong Sacred Heart Hospital
Seoul, 134701
Gangnam Severance Hospital
Seoul, 135720
Sooncunhayng University Hospital Seoul
Seoul, 140887
BORAMAE Medical Center
Seoul, 156707
Chungang University Hospital
Seoul, 156861
Wonju Christian Hospital
Wŏnju, Kangwondo, 220-701
About this study
Official title: A Randomized, Multi-center, Phase IV Open-label Study Evaluating the Antiviral Efficacy of Addition of Vitamin D in Patients With Treatment Naïve Chronic Hepatitis C Receiving Peginterferon Alfa-2a Plus Ribavirin
Standard therapy for chronic hepatitis C virus (HCV) is (Peg/RBV) combination therapy obtaining sustained virologic response (SVR) in 77% of naïve patients with genotype 1-3 Studies rarely address the issues of improving host factors. The current study examines whether adding vitamin D with Peg/RBV, a potent immunomodulator, could improve viral response(SVR)compared to Peg/RBV.
Read the detailed description
The working hypothesis is that Adding vitamin D to conventional Peg/RBV therapy for naïve, genotype 1-3 patients with chronic HCV infection significantly improves RVR, EVR additionally.
- Conditions
- Chronic Hepatitis C
- Being tested
- Vit D
- Keywords
- chronic hepatitis C, SVR, Vit D, 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.
Vit DDrug
800IU/day
| Study group | Role | What they receive |
|---|---|---|
| Peginterferon alfa 2a+Ribavirin | No intervention | standard of care for HCV : peginterferon alfa 2a and ribavirin |
| Vit D+Peginterferon alfa 2a+Ribavirin | Experimental | VitD+Peginterferon alfa 2a+Ribavirin Receives: Drug: Vit D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Sustained virologic response (SVR)
Compare the number of participants with HCV RNA is not detected in the blood at 24 weeks post-treatment between vitamin D and control group.
Measured: 24w after completing Peg/RBV
Secondary outcomes (3)
Number of participants with End of treatment response (ETR)
Compare the number of participants with HCV RNA is not detected in the blood at the end of treatment between two groups.
HCV RNA pCR perform at 48 weeks in genotye 1, at 24 weeks in Genotye 2 and 3
Measured: 48 weeks at Genotype 1, 24 weeks at Genotye 2 and 3
Number of participants with Rapid virological response (RVR)
Compare the number of participants with HCV RNA is notdetectable in the blood at week 4 of treatment between vitamin and control group
Measured: Week 4
Number of participants with Early virological response (EVR)
Compare the number of participants with HCV RNA cannot be detected in the blood at week 12 of treatment between viatmin and control group
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2011 (estimated)
- Study startSep 2011
- Primary completion15 Dec 2017
- Study completion20 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis CStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Control: Peg-ING + ribavirin Treatment: peg-INF+ ribavirin + Vitamin D
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanyang University
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Responsible party
- Principal investigator, Dae Won Jun, Hanyang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01439776
- Sponsor's protocol ID
- ML25569
- Acronym
- Addwin
- Status last verified
- Mar 2023
- First submitted
- 16 Sep 2011
- Last updated
- 6 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multi-center, Phase IV Open-label Study Evaluating the Antiviral Efficacy of Addition of Vitamin D in Patients With Treatment Naïve Chronic Hepatitis C Receiving Peginterferon Alfa-2a Plus Ribavirin
- ClinicalTrials.gov ID
- NCT01439776
- Acronym / sponsor ID
- Addwin / ML25569
- Conditions
- Chronic Hepatitis C
- Keywords
- chronic hepatitis C, SVR, Vit D, Peginterferon alfa 2a, Ribavirin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Hanyang UniversityUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- Sep 2011
- Primary completion
- 15 Dec 2017 (actual)
- Study completion
- 20 Jan 2018 (actual)
- First posted
- 23 Sep 2011 (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.
Standard therapy for chronic hepatitis C virus (HCV) is (Peg/RBV) combination therapy obtaining sustained virologic response (SVR) in 77% of naïve patients with genotype 1-3 Studies rarely address the issues of improving host factors. The current study examines whether adding vitamin D with Peg/RBV, a potent immunomodulator, could improve viral response(SVR)compared to Peg/RBV.
Detailed description
The working hypothesis is that Adding vitamin D to conventional Peg/RBV therapy for naïve, genotype 1-3 patients with chronic HCV infection significantly improves RVR, EVR additionally.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Control: Peg-ING + ribavirin Treatment: peg-INF+ ribavirin + Vitamin D
| Arm | Type | Receives |
|---|---|---|
| Peginterferon alfa 2a+Ribavirin | No intervention | –standard of care for HCV : peginterferon alfa 2a and ribavirin |
| Vit D+Peginterferon alfa 2a+Ribavirin | Experimental | Drug: Vit DVitD+Peginterferon alfa 2a+Ribavirin |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Chronic genotype 1-3 HCV infection
- Treatment Naive
Key exclusion criteria (3 listed)
- Child B and C
- HCC patients
- Pregnancy
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 |
|---|---|---|
| Vit D800IU/day | Drug | Vit D+Peginterferon alfa 2a+Ribavirin |
Primary outcome
Number of participants with Sustained virologic response (SVR)
Time frame: 24w after completing Peg/RBV
Compare the number of participants with HCV RNA is not detected in the blood at 24 weeks post-treatment between vitamin D and control group.
3 secondary outcomes
Number of participants with End of treatment response (ETR)
Time frame: 48 weeks at Genotype 1, 24 weeks at Genotye 2 and 3
Number of participants with Rapid virological response (RVR)
Time frame: Week 4
Number of participants with Early virological response (EVR)
Time frame: Week 12
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 6 Mar 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vit D in people with Chronic Hepatitis C, run by Hanyang University at 13 sites in South Korea.
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 2 inclusion and 3 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 6 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in South Korea. 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?
Number of participants with Sustained virologic response (SVR) (time frame: 24w after completing Peg/RBV). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Mar 2023.