Primary Sclerosing CholangitisPhase 2NCT01688024
Mitomycin C Therapy for Patients With Primary Sclerosing Cholangitis
A Phase 2 study testing Mitomycin C and Normal saline in people with Primary Sclerosing Cholangitis, run by Li, Zhiping, M.D. at 1 site in United States.
Trial summary
The purpose of this study is to determine the effectiveness and safety of mitomycin C in the treatment of primary sclerosing cholangitis (PSC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Sclerosing Cholangitis
- What is being tested?
- Mitomycin C and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Sep 2019
- Phase
- Phase 2
- 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
- Ages 18 or older
- Previously established diagnosis of primary sclerosing cholangitis
Who cannot join
- American Society of Anesthesiologists class 4 or greater
- Serum creatinine >= 1.7 mg/dL, eGFR <= 30 mL/min, or dialysis dependence
- Serum hemoglobin <= 7 g
- Left ventricular ejection fraction <= 30%
- Dyspnea with minimal exertion (or supplemental oxygen dependence)
- History of bone marrow disease
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- Prior recipient of organ transplantation
- Ongoing chemotherapy
- Obstruction of the upper GI tract
- Pregnant or lactating
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21288
Zhiping Li, M.D.
About this study
Official title: Phase 2 Study of Mitomycin C Therapy for Biliary Strictures in Patients With Primary Sclerosing Cholangitis
The purpose of this study is to determine the effectiveness and safety of mitomycin C in the treatment of primary sclerosing cholangitis (PSC).
- Conditions
- Primary Sclerosing Cholangitis
- Being tested
- Mitomycin C, Normal saline
- Keywords
- mitomycin C
- Medical subject headings
- Cholangitis, Sclerosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitomycin CDrug
Normal salineDrug
| Study group | Role | What they receive |
|---|---|---|
| Mitomycin C | Experimental | Up to 10 mg administered during each standard of care endoscopic retrograde cholangiography. No more than five mitomycin C applications per every twelve months will be given. Receives: Drug: Mitomycin C |
| Normal saline | Placebo comparator | Given during each standard of care endoscopic retrograde cholangiography. No more than five normal saline applications per every twelve months will be performed. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic Effect on Disease Prognosis as Determined by the Mayo Natural History Model for Primary Sclerosing Cholangitis
Measured: Two years
Secondary outcomes (2)
Number of Patients with Adverse Events
Measured: Two years
Frequency of Endoscopic Interventions Needed to Manage Disease-related Complications
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2017 (estimated)
- Study completionSep 2019 (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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Li, Zhiping, M.D.
- Collaborators
- Johns Hopkins University
- Responsible party
- Sponsor
- Investigators
- Zhiping Li, M.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01688024
- Sponsor's protocol ID
- NA_00052685
- Status last verified
- Sep 2016
- First submitted
- 10 Sep 2012
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Mitomycin C Therapy for Biliary Strictures in Patients With Primary Sclerosing Cholangitis
- ClinicalTrials.gov ID
- NCT01688024
- Acronym / sponsor ID
- NA_00052685
- Conditions
- Primary Sclerosing Cholangitis
- Keywords
- mitomycin C
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Li, Zhiping, M.D.
- Collaborators
- Johns Hopkins University
- Study start
- Sep 2012
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 19 Sep 2012 (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 the effectiveness and safety of mitomycin C in the treatment of primary sclerosing cholangitis (PSC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mitomycin C | Experimental | Drug: Mitomycin CUp to 10 mg administered during each standard of care endoscopic retrograde cholangiography. No more than five mitomycin C applications per every twelve months will be given. |
| Normal saline | Placebo comparator | Drug: Normal salineGiven during each standard of care endoscopic retrograde cholangiography. No more than five normal saline applications per every twelve months will be performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ages 18 or older
- Previously established diagnosis of primary sclerosing cholangitis
Key exclusion criteria (11 listed)
- American Society of Anesthesiologists class 4 or greater
- Serum creatinine >= 1.7 mg/dL, eGFR <= 30 mL/min, or dialysis dependence
- Serum hemoglobin <= 7 g
- Left ventricular ejection fraction <= 30%
- Dyspnea with minimal exertion (or supplemental oxygen dependence)
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 |
|---|---|---|
| Mitomycin C | Drug | Mitomycin C |
| Normal saline | Drug | Normal saline |
Primary outcome
Therapeutic Effect on Disease Prognosis as Determined by the Mayo Natural History Model for Primary Sclerosing Cholangitis
Time frame: Two years
2 secondary outcomes
Number of Patients with Adverse Events
Time frame: Two years
Frequency of Endoscopic Interventions Needed to Manage Disease-related Complications
Time frame: Two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2016.
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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.
Zhiping Li, M.D. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mitomycin C and Normal saline in people with Primary Sclerosing Cholangitis, run by Li, Zhiping, M.D. at 1 site in United States.
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 11 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 7 Sep 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Po-Hung Chen, M.D. (410-502-6072, pchen37@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Therapeutic Effect on Disease Prognosis as Determined by the Mayo Natural History Model for Primary Sclerosing Cholangitis (time frame: Two years). 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 7 Sep 2016.