Mitomycin C Therapy for Patients With Primary Sclerosing... | NCT01688024

Studies
Mitomycin C Therapy for Patients With Primary Sclerosing Cholangitis

NCT01688024

Sponsor

Li, Zhiping, M.D.

Status

Unknown status

Last Update Posted

Sep 7, 2016Estimated

Enrollment

130Estimated

Phase

Phase 2

Conditions

Primary Sclerosing Cholangitis

Interventions

Mitomycin C
Normal saline

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2012

Primary Completion Date

Sep 2017Estimated

Completion Date

Sep 2019Estimated

First Submitted Date

Sep 10, 2012

First Submission Date that Met QC Criteria

Sep 14, 2012

First Posted Date

Sep 19, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 6, 2016

Last Update Posted Date

Sep 7, 2016Estimated

Name	Class
Johns Hopkins University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine the effectiveness and safety of mitomycin C in the treatment of primary sclerosing cholangitis (PSC).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

130Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	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.	Drug: Normal saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mitomycin C	Drug		Mitomycin C
Normal saline

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Therapeutic Effect on Disease Prognosis as Determined by the Mayo Natural History Model for Primary Sclerosing Cholangitis		Two years

Secondary Outcomes

Measure	Description	Time Frame
Number of Patients with Adverse Events		Two years
Frequency of Endoscopic Interventions Needed to Manage Disease-related Complications		Two years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ages 18 or older
Previously established diagnosis of primary sclerosing cholangitis

Exclusion Criteria:

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
Prior recipient of organ transplantation
Ongoing chemotherapy
Obstruction of the upper GI tract
Pregnant or lactating
Inability to provide informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Po-Hung Chen, M.D.	Contact	410-502-6072		pchen37@jhmi.edu
Tinsay A. Woreta, M.D., M.P.H.	Contact	410-955-2635		tworeta1@jhmi.edu

Overall Officials

Name	Affiliation	Role
Zhiping Li, M.D.	Johns Hopkins University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Johns Hopkins Hospital	Recruiting	Baltimore	Maryland	21288	United States

Condition Browse Module

MeSH Terms

ID	Term
D015209	Cholangitis, Sclerosing

Ancestor Terms

ID	Term
D002761	Cholangitis
D001649	Bile Duct Diseases
D001660	Biliary Tract Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016685	Mitomycin
D000077330	Saline Solution

Ancestor Terms

ID	Term
D008937	Mitomycins
D045563	Indolequinones
D011809	Quinones
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided