Severe Alcoholic HepatitisPhase 4NCT02161653
Metadoxine as a Therapy for Severe Alcoholic Hepatitis
A Phase 4 study testing Prednisone plus Metadoxine and Pentoxifylline plus Metadoxine in people with Severe Alcoholic Hepatitis, run by Hospital General de Mexico at 1 site in Mexico.
Trial summary
The purpose of this study is to determine whether metadoxine is effective for improve survival and reduced oxidative stress in patients with severe alcoholic hepatitis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Severe Alcoholic Hepatitis
- What is being tested?
- Prednisone plus Metadoxine and Pentoxifylline plus Metadoxine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteMexico
- Study dates
- Apr 2010to Sep 2014
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with clinical and biochemical criteria for severe alcoholic hepatitis: Total bilirubin greater than 5 mg/dl in absence of biliary tract obstruction evidenced by ultrasound, history of chronic alcohol intake, leukocytosis, neutrophilia, elevation of transaminases with an aspartate aminotransferase / alanine aminotransferase ratio equal or greater than 2, discriminant function greater than 32.
Who cannot join
- Diabetes, chronic kidney disease, hepatitis C, hepatitis B and or human immunodeficiency virus infection, asthma or history of atopy or allergic reactions, therapy in the previous two years with steroids, pentoxifylline, metadoxine, S-adenosyl L- methionine, antioxidants or multivitamins.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Metadoxine in the Oxidative Stress and Early Mortality in Patients With Severe Alcoholic Hepatitis
The purpose of this study is to determine whether metadoxine is effective for improve survival and reduced oxidative stress in patients with severe alcoholic hepatitis.
- Conditions
- Severe Alcoholic Hepatitis
- Being tested
- Prednisone plus Metadoxine, Pentoxifylline plus Metadoxine
- Keywords
- Severe alcoholic hepatitis, survival, oxidative stress
- Medical subject headings
- Hepatitis, Alcoholic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prednisone plus MetadoxineDrug
Pentoxifylline plus MetadoxineDrug
| Study group | Role | What they receive |
|---|---|---|
| Prednisone | No intervention | Prednisone 40 mg daily by mouth during 30 days. |
| Pentoxifylline | No intervention | Pentoxifylline 400 mg thrice in day by mouth during 30 days |
| Prednisone plus metadoxine | Experimental | Prednisone 40 mg daily by mouth plus Metadoxine 500 mg thrice in day by mouth during 30 days. Receives: Drug: Prednisone plus Metadoxine |
| Pentoxifylline plus metadoxine | Experimental | Pentoxifylline 400 mg thrice in day by mouth plus Metadoxine 500 mg thrice in day by mouth during 30 days. Receives: Drug: Pentoxifylline plus Metadoxine |
What is being measured
The primary outcome is the main question the study is designed to answer.
30 day-survival
Measured: 30 days
Malondialdehyde serum levels
Measured: 14 and 30 days
Secondary outcomes (2)
3 month-survival
Measured: 3 months
6 month-survival
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2014 (estimated)
- Study startApr 2010
- Primary completionSep 2014
- Study completionSep 2014
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 Severe Alcoholic HepatitisStudies 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
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General de Mexico
- Sponsor type
- Other government
- Responsible party
- Principal investigator, MARIA DE FATIMA HIGUERA DE LA TIJERA, Hospital General de Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02161653
- Sponsor's protocol ID
- DI/10/107/3/43
- Status last verified
- Nov 2014
- First submitted
- 10 Jun 2014
- Last updated
- 11 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Higuera-de la Tijera F, Servin-Caamano AI, Serralde-Zuniga AE, Cruz-Herrera J, Perez-Torres E, Abdo-Francis JM, Salas-Gordillo F, Perez-Hernandez JL. Metadoxine improves the three- and six-month survival rates in patients with severe alcoholic hepatitis. World J Gastroenterol. 2015 Apr 28;21(16):4975-85. doi: 10.3748/wjg.v21.i16.4975.
PubMed 25945012
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Metadoxine in the Oxidative Stress and Early Mortality in Patients With Severe Alcoholic Hepatitis
- ClinicalTrials.gov ID
- NCT02161653
- Acronym / sponsor ID
- DI/10/107/3/43
- Conditions
- Severe Alcoholic Hepatitis
- Keywords
- Severe alcoholic hepatitis, survival, oxidative stress
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Hospital General de MexicoOther government
- Study start
- Apr 2010
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 12 Jun 2014 (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.
The purpose of this study is to determine whether metadoxine is effective for improve survival and reduced oxidative stress in patients with severe alcoholic hepatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Prednisone | No intervention | –Prednisone 40 mg daily by mouth during 30 days. |
| Pentoxifylline | No intervention | –Pentoxifylline 400 mg thrice in day by mouth during 30 days |
| Prednisone plus metadoxine | Experimental | Drug: Prednisone plus MetadoxinePrednisone 40 mg daily by mouth plus Metadoxine 500 mg thrice in day by mouth during 30 days. |
| Pentoxifylline plus metadoxine | Experimental | Drug: Pentoxifylline plus MetadoxinePentoxifylline 400 mg thrice in day by mouth plus Metadoxine 500 mg thrice in day by mouth during 30 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with clinical and biochemical criteria for severe alcoholic hepatitis: Total bilirubin greater than 5 mg/dl in absence of biliary tract obstruction evidenced by ultrasound, history of chronic alcohol intake, leukocytosis, neutrophilia, elevation of transaminases with an aspartate aminotransferase / alanine aminotransferase ratio equal or greater than 2, discriminant function greater than 32.
Key exclusion criteria (1 listed)
- Diabetes, chronic kidney disease, hepatitis C, hepatitis B and or human immunodeficiency virus infection, asthma or history of atopy or allergic reactions, therapy in the previous two years with steroids, pentoxifylline, metadoxine, S-adenosyl L- methionine, antioxidants or multivitamins.
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 |
|---|---|---|
| Prednisone plus Metadoxine | Drug | Prednisone plus metadoxine |
| Pentoxifylline plus Metadoxine | Drug | Pentoxifylline plus metadoxine |
Primary outcome
30 day-survival
Time frame: 30 days
Malondialdehyde serum levels
Time frame: 14 and 30 days
2 secondary outcomes
3 month-survival
Time frame: 3 months
6 month-survival
Time frame: 6 months
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 11 Nov 2014.
- Derived from this study: PubMed 25945012Higuera-de la Tijera F, Servin-Caamano AI, Serralde-Zuniga AE, Cruz-Herrera J, Perez-Torres E, Abdo-Francis JM, Salas-Gordillo F, Perez-Hernandez JL. Metadoxine improves the three- and six-month survival rates in patients with severe alcoholic hepatitis. World J Gastroenterol. 2015 Apr 28;21(16):4975-85. doi: 10.3748/wjg.v21.i16.4975.
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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.
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 Prednisone plus Metadoxine and Pentoxifylline plus Metadoxine in people with Severe Alcoholic Hepatitis, run by Hospital General de Mexico at 1 site in Mexico.
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 1 inclusion and 1 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 11 Nov 2014. 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 Mexico. 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?
30 day-survival (time frame: 30 days). The study lists 2 primary outcomes in all. 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 NCT02161653, 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 11 Nov 2014.