Chronic HepatitisPhase 4NCT01413360
The Effect of High Dose Vitamin C on the Liver Function in Chronic Hepatitis Patients
A Phase 4 study testing High dose vitamin C in people with Chronic Hepatitis and Chronic Hepatitis C, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The investigators will evaluate the efficacy of high dose vitamin C in chronic hepatitis patients whose serum liver enzymes are elevated more than upper limit. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Hepatitis, Chronic Hepatitis C, Chronic Alcoholic Hepatitis
- What is being tested?
- High dose vitamin C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2011to Dec 2014
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic hepatitis C patients
- positive anti-HCV antibody more than 6 months
- serum alanine aminotransferase 40 - 80 IU/L for more than 6 months
- not indicated for antiviral therapy with interferon and ribavirin
- Chronic alcoholic hepatitis
- significant alcohol drinking history and no other cause of chronic hepatitis
- serum alanine aminotransferase 40 - 80 IU/L for more than 6 months
Who cannot join
- Chronic hepatitis B, autoimmune hepatitis, primary biliary cirrhosis, Wilson's disease, hemochromatosis, other chronic hepatitis except chronic hepatitis C or alcoholic hepatitis
- decompensated liver cirrhosis
- platelet < 50,000/uL or white blood cell < 1,500/uL
- need and willing for antiviral therapy
- significant renal dysfunction (GFR < 30 mL/min/kg) or history of renal stone
- hepatotonic drug (i.e. silymarin, garlic oil, aronamin gold) usage within 2 weeks
- pregnancy, lactating woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 4 Study of High Dose Vitamin C in Chronic Hepatitis Patients
The investigators will evaluate the efficacy of high dose vitamin C in chronic hepatitis patients whose serum liver enzymes are elevated more than upper limit.
Read the detailed description
The changes of laboratory findings including serum transaminase levels, serum albumin levels, Child-Pugh score, MELD score, and APRI score will be evaluated.
- Being tested
- High dose vitamin C
- Medical subject headings
- Hepatitis, Chronic, Hepatitis C, Chronic, Hepatitis, Alcoholic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High dose vitamin CDrug
Also called Koreaeundan Vitamin C 1000
Vitamin C, 3g per day (tid), with meal, per oral with water 100mL
| Study group | Role | What they receive |
|---|---|---|
| HD Vitamin C | Experimental | High dose vitamin C Receives: Drug: High dose vitamin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Change in Serum Alanine Aminotransferase Level From Baseline to 12 Weeks
Serum alanine aminotransferase (ALT) level after 12 weeks of high dose vitamin C administration and Baseline serum ALT level
Measured: Baseline and 12 weeks
Secondary outcomes (1)
The Change in Serum Interleukin 22 Level From Baseline to 12 Weeks
Serum interleukin 22(IL-22)level after 12 weeks of high vitamin C administration and Baseline IL-22 level
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2013
- Study completionDec 2014
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.
- Other trials for Chronic HepatitisStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jung-Hwan Yoon, Seoul National University Hospital
- Investigators
- Jung-Hwan Yoon, M.D, Ph.D, Study director, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01413360
- Sponsor's protocol ID
- VitC
- Status last verified
- Jun 2016
- First submitted
- 9 Aug 2011
- Last updated
- 15 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of High Dose Vitamin C in Chronic Hepatitis Patients
- ClinicalTrials.gov ID
- NCT01413360
- Acronym / sponsor ID
- VitC
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 10 Aug 2011 (estimated)
- Results
- Posted 15 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will evaluate the efficacy of high dose vitamin C in chronic hepatitis patients whose serum liver enzymes are elevated more than upper limit.
Detailed description
The changes of laboratory findings including serum transaminase levels, serum albumin levels, Child-Pugh score, MELD score, and APRI score will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HD Vitamin C | Experimental | Drug: High dose vitamin CHigh dose vitamin C |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Chronic hepatitis C patients
- Chronic alcoholic hepatitis
Key exclusion criteria (7 listed)
- Chronic hepatitis B, autoimmune hepatitis, primary biliary cirrhosis, Wilson's disease, hemochromatosis, other chronic hepatitis except chronic hepatitis C or alcoholic hepatitis
- decompensated liver cirrhosis
- platelet < 50,000/uL or white blood cell < 1,500/uL
- need and willing for antiviral therapy
- significant renal dysfunction (GFR < 30 mL/min/kg) or history of renal stone
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 |
|---|---|---|
| High dose vitamin CAlso: Koreaeundan Vitamin C 1000Vitamin C, 3g per day (tid), with meal, per oral with water 100mL | Drug | HD Vitamin C |
Primary outcome
The Change in Serum Alanine Aminotransferase Level From Baseline to 12 Weeks
Time frame: Baseline and 12 weeks
Serum alanine aminotransferase (ALT) level after 12 weeks of high dose vitamin C administration and Baseline serum ALT level
1 secondary outcome
The Change in Serum Interleukin 22 Level From Baseline to 12 Weeks
Time frame: Baseline and 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Chronic Hepatitis
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B
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.
Jung-Hwan Yoon, M.D, Ph.D study director
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing High dose vitamin C in people with Chronic Hepatitis and Chronic Hepatitis C, run by Seoul National University Hospital at 1 site 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 7 inclusion and 7 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 15 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 15 Jul 2016). 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?
The Change in Serum Alanine Aminotransferase Level From Baseline to 12 Weeks (time frame: Baseline and 12 weeks). 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 15 Jul 2016.