Primary Sclerosing CholangitisPhase 4NCT02605213
Effect and Safety of Oral Vancomycin in Primary Sclerosing Cholangitis Patients
A Phase 4 study testing Vancomycin in people with Primary Sclerosing Cholangitis, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
Primary sclerotic cholangitis (PSC) is an inflammatory process of sclerotic cholangitis that involves intra and extra hepatic biliary system. There is no curative treatment for this disorder. Supportive and conservative treatments are the most common therapies that used for this disease. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Primary Sclerosing Cholangitis
- What is being tested?
- Vancomycin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteIran
- Study dates
- Sep 2015to Feb 2016
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- primary sclerosing chollangitis diagnosis more than 3 months
- inflammatory bowel disease with cholestasis diagnosis more than 3 months
- confirmed RCPM
- confirmed pathology of inflammatory bowel disease
Who cannot join
- signs of uncompensated cirrhosis like: hepatic encephalopathy, esophageal varices bleeding
- gastrointestinal cancer or hepatic cancer
- immunosuppressive agent using for hepatic problem (not vancomycine hypersensitivity)
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Imam khomeini Hospital Complex
Tehran, Tehran Province, 1419733141
Naser Ebrahimi Daryani, Professor, +989121104517, nasere@yahoo.com
About this study
Official title: Evaluation of Effectiveness and Safety of Oral Vancomycin in Treatment of Primary Sclerosing Cholangitis.
Primary sclerotic cholangitis (PSC) is an inflammatory process of sclerotic cholangitis that involves intra and extra hepatic biliary system. There is no curative treatment for this disorder. Supportive and conservative treatments are the most common therapies that used for this disease. Although treatments such as ursodeoxycholic acid (UDCA) are recommended in some situations but whereas a hypothesis is stimulatory effect of intestinal anaerobic bacteria such as cholestridium difficile as pathogenesıs of PSC, so use of antibiotics is recommended for treatment of these patients. Therefore according to the great role of anaerobic bacteria such as cholestridium difficile in pathogenesis, antibiotics such as metronidazole and vancomycin can be counted as recommended therapies in PSC. In addition some studies correlated this effect of vancomycin to its immunomudulatory effect the cause reduction of inflammation in biliary system. But with all this detail there is no finality about effectiveness of antibiotic therapy and accordingly in this study the investigators compare oral vancomycin effect versus placebo in primary sclerosing cholangitis patients.
In this double blind clinical trial 30 primary sclerosing cholangitis patients that divided in two 15 persosns group with Block Randomization method. in this study one group receive 250 mg oral vancomycin every 6 hours and other group receive placebo.
The study duration is 12 weeks . The baseline laboratory tests and 1 month and 3 months after treatment concept of; Alkaline phosphatase, ALT, AST, GGT and serum total bilirubin and clinical manifestations such as tiredness, itching and probable adverse effects such as hypotension accompanied by flushing,erythematous rash on face and upper body (red neck or red man syndrome), chills and drug fever, eosinophilia and reversible neutropenia.
- Conditions
- Primary Sclerosing Cholangitis
- Being tested
- Vancomycin, Placebo
- Medical subject headings
- Cholangitis, Sclerosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VancomycinDrug
Also called Vancomycin hydrochloride,
Vancomycin for treatment of primary sclerosing cholangitis
PlaceboDrug
Placebo for control Group of primary sclerosing vhlangitis
| Study group | Role | What they receive |
|---|---|---|
| Vancomycin | Experimental | Vancomyicn 250 mg every 6 hours for 12 weeks Receives: Drug: Vancomycin |
| Placebo | Placebo comparator | placebo every 6 hours for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of laboratory data Alkalyne phosphatase between baseline and after treatment
Alkaline phosphatase
Measured: 12 weeks
comparison of laboratory data ALT between baseline and after treatment
ALT
Measured: 12 weeks
comparison of laboratory data AST between baseline and after treatment
AST
Measured: 12 weeks
comparison of laboratory data GGT between baseline and after treatment
GGT
Measured: 12 weeks
comparison of laboratory data serum total bilirubin between baseline and after treatment
serum total bilirubin
Measured: 12 weeks
baseline data
serum Albumin
Measured: baseline
Secondary outcomes (1)
Number of participants with adverse events
clinical manifestations such as tiredness, itching and probable adverse effects such as hypotension accompanied by flushing,erythematous rash on face and upper body (red neck or red man syndrome), chills and drug fever, eosinophilia and reversible neutropenia.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2015 (estimated)
- Study startSep 2015
- Primary completionFeb 2016 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Sclerosing CholangitisStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nasser Ebrahim Daryani, Tehran University of Medical Sciences
- Investigators
- Shahab Rahimpour, fellowship, Principal investigator, Tehran University of Medical SciencesMohammad Kazem NouriTaromlou, M.D., Study director, Tehran UMSNaser Ebrahimi Daryani, Professor, Study director, Tehran University of Medical SciencesSanam Javidanbardan, M.D., Study director, Tehran University of Medical SciencesZahra Azizi, M.D., Study director, Tehran University of Medical SciencesMohsen Nasiri Toosi, Professor, Study director, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02605213
- Sponsor's protocol ID
- 9311366004
- Status last verified
- Nov 2015
- First submitted
- 31 Oct 2015
- Last updated
- 16 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Effectiveness and Safety of Oral Vancomycin in Treatment of Primary Sclerosing Cholangitis.
- ClinicalTrials.gov ID
- NCT02605213
- Acronym / sponsor ID
- 9311366004
- Conditions
- Primary Sclerosing Cholangitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 16 Nov 2015 (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.
Primary sclerotic cholangitis (PSC) is an inflammatory process of sclerotic cholangitis that involves intra and extra hepatic biliary system. There is no curative treatment for this disorder. Supportive and conservative treatments are the most common therapies that used for this disease. Although treatments such as ursodeoxycholic acid (UDCA) are recommended in some situations but whereas a hypothesis is stimulatory effect of intestinal anaerobic bacteria such as cholestridium difficile as pathogenesıs of PSC, so use of antibiotics is recommended for treatment of these patients. Therefore according to the great role of anaerobic bacteria such as cholestridium difficile in pathogenesis, antibiotics such as metronidazole and vancomycin can be counted as recommended therapies in PSC. In addition some studies correlated this effect of vancomycin to its immunomudulatory effect the cause reduction of inflammation in biliary system. But with all this detail there is no finality about effectiveness of antibiotic therapy and accordingly in this study the investigators compare oral vancomycin effect versus placebo in primary sclerosing cholangitis patients.
In this double blind clinical trial 30 primary sclerosing cholangitis patients that divided in two 15 persosns group with Block Randomization method. in this study one group receive 250 mg oral vancomycin every 6 hours and other group receive placebo.
The study duration is 12 weeks . The baseline laboratory tests and 1 month and 3 months after treatment concept of; Alkaline phosphatase, ALT, AST, GGT and serum total bilirubin and clinical manifestations such as tiredness, itching and probable adverse effects such as hypotension accompanied by flushing,erythematous rash on face and upper body (red neck or red man syndrome), chills and drug fever, eosinophilia and reversible neutropenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vancomycin | Experimental | Drug: VancomycinVancomyicn 250 mg every 6 hours for 12 weeks |
| Placebo | Placebo comparator | Drug: Placeboplacebo every 6 hours for 12 weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- primary sclerosing chollangitis diagnosis more than 3 months
- inflammatory bowel disease with cholestasis diagnosis more than 3 months
- confirmed RCPM
- confirmed pathology of inflammatory bowel disease
Key exclusion criteria (3 listed)
- signs of uncompensated cirrhosis like: hepatic encephalopathy, esophageal varices bleeding
- gastrointestinal cancer or hepatic cancer
- immunosuppressive agent using for hepatic problem (not vancomycine hypersensitivity)
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 |
|---|---|---|
| VancomycinAlso: Vancomycin hydrochloride,Vancomycin for treatment of primary sclerosing cholangitis | Drug | Vancomycin |
| PlaceboPlacebo for control Group of primary sclerosing vhlangitis | Drug | Placebo |
Primary outcome
comparison of laboratory data Alkalyne phosphatase between baseline and after treatment
Time frame: 12 weeks
Alkaline phosphatase
comparison of laboratory data ALT between baseline and after treatment
Time frame: 12 weeks
ALT
comparison of laboratory data AST between baseline and after treatment
Time frame: 12 weeks
AST
comparison of laboratory data GGT between baseline and after treatment
Time frame: 12 weeks
GGT
comparison of laboratory data serum total bilirubin between baseline and after treatment
Time frame: 12 weeks
serum total bilirubin
baseline data
Time frame: baseline
serum Albumin
1 secondary outcome
Number of participants with adverse events
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2015.
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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.
Shahab Rahimpour, fellowship principal investigator
Tehran University of Medical Sciences
Mohammad Kazem NouriTaromlou, M.D. study director
Tehran UMS
Naser Ebrahimi Daryani, Professor study director
Tehran University of Medical Sciences
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 Vancomycin in people with Primary Sclerosing Cholangitis, run by Tehran University of Medical Sciences at 1 site in Iran.
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 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: status not confirmed, as of the sponsor's last update on 16 Nov 2015. 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 Iran. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Naser Ebrahimi Daryani, Professor (+989121104517, nasere@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison of laboratory data Alkalyne phosphatase between baseline and after treatment (time frame: 12 weeks). The study lists 6 primary outcomes in all. 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 16 Nov 2015.