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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:  NCT02559713
Date of registration: 23/09/2015
Prospective Registration: Yes
Primary sponsor: Takeda
Public title: Postmarketing Vedolizumab Milk-Only Lactation Study in Lactating Women With Active Ulcerative Colitis or Crohn's Disease
Scientific title: An Open-Label, Multicenter and Open Enrollment Model, Postmarketing, Milk-Only Lactation Study to Assess Concentration of Vedolizumab in Breast Milk of Lactating Women With Active Ulcerative Colitis or Crohn's Disease Who Are Receiving Vedolizumab Therapeutically
Date of first enrolment: November 29, 2017
Target sample size: 11
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02559713
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 4
Countries of recruitment
United States
Contacts
Name:     Medical Director
Address: 
Telephone:
Email:
Affiliation:  Takeda
Key inclusion & exclusion criteria

Inclusion Criteria:

1. Is capable of understanding and complying with protocol requirements.

2. Signs and dates as written, informed consent form and any required privacy
authorization prior to the initiation of any study procedures.

3. Is female and at least 18 years of age at the time of informed consent.

4. A female participant of childbearing potential who is sexually active with a
nonsterilized male partner agrees to use routinely adequate contraception from signing
of informed consent and throughout the duration of the study.

5. Is on established vedolizumab maintenance therapy and received at least 1 dose of 300
mg of vedolizumab IV postpartum or has completed vedolizumab induction therapy (300 mg
of vedolizumab IV at Week 0, Week 2, and Week 6), which has been commenced by the
participant's treating physician for the treatment of active UC or CD prior to
enrolling in this study.

6. Has delivered a single, normal term infant (at least 37 weeks' gestation) that is, a
mother-infant pair is required.

7. Is at least 5 weeks postpartum by Day 1.

8. Lactation is well established, and the mother is exclusively breast feeding her infant
(or not providing more than 1 supplemental bottle of formula/day) when enrolled in the
study.

9. Participant has independently decided to be treated with vedolizumab or to breastfeed
prior to providing consent to participate in this study.

10. Plans to continue breastfeeding at least throughout the duration of this study.

11. Agrees to use only the emollient or nipple cream recommended by the investigator for
use during the sampling period.

Exclusion Criteria:

1. Has received any investigational compound or approved biologic or biosimilar agent,
except for vedolizumab within 60 days prior to enrollment in the study.

2. Within 30 days prior to enrollment, the participant has received any of the following
for the treatment of underlying disease:

- Nonbiologic therapies [example (eg), cyclosporine], other than those listed in
the protocol.

- An approved nonbiologic therapy in an investigational protocol.

3. Has received any live vaccinations within 30 days prior to vedolizumab administration.

4. Has clinically significant infection (eg, pneumonia, pyelonephritis) or chronic
infection within 30 days prior to enrollment.

5. Is an immediate family member, study site employee, or is in a dependent relationship
with a study site employee who is involved in the conduct of this study (eg, spouse,
parent, child, sibling) or may consent under duress.

6. Has evidence of unstable or uncontrolled, clinically significant cardiovascular,
central nervous system, pulmonary, hepatic, renal, gastrointestinal, genitourinary,
hematological, coagulation, immunological, endocrine/metabolic or other medical
disorder, including serious allergy, asthma, hypoxemia, hypertension, seizures or
allergic skin rash that, in the opinion of the investigator, would confound the study
results or compromise participant safety. Additionally, if there is any finding in the
participant's medical history, physical examination, or safety laboratory tests giving
reasonable suspicion of a disease that would contraindicate taking vedolizumab, or a
similar drug that might interfere with the conduct of the study.

7. Had any surgical procedure requiring general anesthesia within 30 days prior to
enrollment or is planning to undergo major surgery during the study period.

8. Has any history of malignancy, except for the following: (a) adequately treated
nonmetastatic basal cell skin cancer; (b) squamous cell skin cancer that has been
adequately treated and that has not recurred for at least 1 year prior to enrollment;
and (c) history of cervical carcinoma in situ that has been adequately treated and
that has not recurred for at least 3 years prior to enrollment. Participants with
remote history of malignancy (eg, greater than (>) 10 years since completion of
curative therapy without recurrence) will be considered based on the nature of the
malignancy and the therapy received and must be discussed with the sponsor on a
case-by-case basis prior to enrollment.

9. Has a history of any major neurological disorders, including stroke, multiple
sclerosis, brain tumor, or neurodegenerative disease.

10. Has a positive progressive multifocal leukoencephalopathy subjective symptom checklist
at screening.

11. Has a current or recent history (within 1 year prior to enrollment) of alcohol
dependence or illicit drug use.

12. Has active psychiatric problems that, in the investigator's opinion, may interfere
with compliance with the study procedures.

13. Is unable to participate in all the study visits or comply with study procedures.

14. Has history of breast implants, breast augmentation, or breast reduction surgery.

15. Has a prior history of difficulty establishing lactation.

16. Has taken any excluded medication, supplements, or food products during the time
periods listed in the Excluded Medications and Dietary Products table.

17. Has donated or lost 450 milliliters or more of her blood volume (including
plasmapheresis), or had a transfusion of any blood product within 45 days prior to Day
1.



Age minimum: 18 Years
Age maximum: N/A
Gender: Female
Health Condition(s) or Problem(s) studied
Colitis, Ulcerative
Crohn's Disease
Intervention(s)
Drug: Vedolizumab
Primary Outcome(s)
Concentration of Vedolizumab in Breast Milk at 1 Hour After the End of Infusion on Day 1 [Time Frame: Day 1 (approximately 60 minutes after the end of infusion)]
Concentration of Vedolizumab in Breast Milk at Predose on Day 1 [Time Frame: Day 1 (60 minutes prior to the start of infusion)]
Concentration of Vedolizumab in Breast Milk on Day 15 [Time Frame: Day 15]
Concentration of Vedolizumab in Breast Milk on Day 29 [Time Frame: Day 29]
Concentration of Vedolizumab in Breast Milk on Day 4 [Time Frame: Day 4]
Concentration of Vedolizumab in Breast Milk on Day 57 [Time Frame: Day 57]
Concentration of Vedolizumab in Breast Milk on Day 8 [Time Frame: Day 8]
Secondary Outcome(s)
Secondary ID(s)
U1111-1171-5296
Vedolizumab-4001
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 04/03/2020
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT02559713
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