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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02365480
Date of registration: 17/02/2015
Prospective Registration: Yes
Primary sponsor: National Cancer Institute (NCI)
Public title: Berberine Chloride in Preventing Colorectal Cancer in Patients With Ulcerative Colitis in Remission
Scientific title: Phase I Trial of Berberine in Subjects With Ulcerative Colitis
Date of first enrolment: June 16, 2016
Target sample size: 18
Recruitment status: Active, not recruiting
URL:  https://clinicaltrials.gov/show/NCT02365480
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Investigator).  
Phase:  Phase 1
Countries of recruitment
China United States
Contacts
Name:     Kaichun Wu
Address: 
Telephone:
Email:
Affiliation:  Northwestern University
Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients with ulcerative colitis in clinical remission (UCDAI) =< 1 for at least 3
months, regardless of how long ago they were diagnosed for UC

- Receiving maintenance therapy with mesalamine for at least 3 months

- Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)

- Leukocytes >= 3,000/microliter

- Absolute neutrophil count >= 1,500/microliter

- Platelets >= 100,000/microliter

- Total bilirubin within normal institutional limits; higher values (=< 3 x
institutional upper limit of normal [ULN]) are acceptable in participants with: 1.
known or suspected cholangitis associated with Crohn's disease, or 2, known or
suspected inborn errors of metabolism that lead to increased bilirubin

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
[SGOP])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
=< 1.5 x institutional ULN

- Creatinine within normal institutional limits

- Women of child-bearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control; abstinence) prior to study entry and for
the duration of study participation; should a woman become pregnant or suspect she is
pregnant while participating in this study, she should inform her study physician
immediately

- Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

- Participants who have had any immunomodulatory treatment in the past 3 months will be
excluded

- Participants who have taken any medicines that are inducers, inhibitors or substrates
of select cytochrome (CYP) isozymes within the past 3 months will be excluded;
participants who have consumed either grapefruit juice or Seville orange juice in the
past 7 days will be excluded

- Participants with dysplasia-associated mass or lesion (DALM) due to longstanding
idiopathic inflammatory bowel disease will be excluded

- Participants who are currently receiving any other investigational agents or have
received investigational agents within the past 3 months will be excluded

- Participants with a history of allergic reactions attributed to compounds of similar
chemical or biologic composition to berberine will be excluded

- Patients with uncontrolled intercurrent illness including, but not limited to, ongoing
or active infection, symptomatic congestive heart failure, unstable angina pectoris,
cardiac arrhythmia, or psychiatric illness/social situations that in the opinion of
investigators would jeopardize patient safety of data integrity are excluded;
individuals who are human immunodeficiency virus (HIV) positive will not necessarily
be excluded, will be considered on a case-by-case basis, but will be required to meet
criteria related to patient safety and data integrity, as assessed by investigators

- Pregnant women are excluded from this study; breastfeeding should be discontinued if
the mother is treated with berberine; women are considered to be of child-bearing
potential if they are not surgically sterile or under the age 65 and have menstruated
within the last two years



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All
Health Condition(s) or Problem(s) studied
Ulcerative Colitis
Intervention(s)
Drug: Berberine Chloride
Other: Laboratory Biomarker Analysis
Other: Placebo Administration
Primary Outcome(s)
Incidence of grade 2 systemic toxicity using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4 [Time Frame: Up to 30 days post-treatment]
Incidence of organ toxicity [Time Frame: Up to 90 days (at the end of treatment)]
Secondary Outcome(s)
Change in blood berberine chloride concentration measurement using high-performance liquid chromatography/mass spectrometry [Time Frame: Baseline up to 90 days]
Change in colorectal tissue biomarkers expression by IHC [Time Frame: Baseline up to 90 days]
Change in gene methylation status using methylation-specific polymerase chain reaction strategy [Time Frame: Baseline up to 90 days]
Change in plasma markers of inflammation via ELISA [Time Frame: Baseline up to 90 days]
Clinical efficacy of berberine chloride measured using the UCDAI score [Time Frame: At day 90]
Severity of histologic inflammation [Time Frame: Up to 90 days]
Secondary ID(s)
N01-CN-2012-00035
N01CN00035
NCI-2015-00173
NCI2014-03-01
NWU2014-03-01
P30CA060553
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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