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Trial record 2 of 46 for:    vedolizumab

Postmarketing Vedolizumab Milk-Only Lactation Study in Lactating Women With Active Ulcerative Colitis or Crohn's Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by Takeda
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT02559713
First received: September 23, 2015
Last updated: September 13, 2016
Last verified: September 2016
  Purpose
The purpose of this study is to assess the concentration of vedolizumab in breast milk of lactating women with active ulcerative colitis (UC) or Crohn's disease (CD) who are receiving vedolizumab therapeutically.

Condition Intervention Phase
Colitis, Ulcerative
Crohn Disease
Drug: Vedolizumab
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Concentration of Vedolizumab in Breast Milk at Predose on Day 1 [ Time Frame: Day 1 (60 minutes prior to the start of infusion) ] [ Designated as safety issue: No ]
    Milk from each breast will be completely emptied using an electric milk pump at the specified time point for the determination of vedolizumab concentrations in the milk. Analysis of vedolizumab concentration from the pooled milk sample will be done by enzyme-linked immunosorbent assay (ELISA).

  • Concentration of Vedolizumab in Breast Milk at 1 Hour After the End of Infusion on Day 1 [ Time Frame: Day 1 (approximately 1 hour after the end of infusion) ] [ Designated as safety issue: No ]
    Milk from each breast will be completely emptied using an electric milk pump at the specified time point for the determination of vedolizumab concentrations in the milk. Analysis of vedolizumab concentration from the pooled milk sample will be done by ELISA.

  • Concentration of Vedolizumab in Breast Milk on Day 4 [ Time Frame: Day 4 ] [ Designated as safety issue: No ]
    Milk from each breast will be completely emptied using an electric milk pump at the specified time point for the determination of vedolizumab concentrations in the milk. Analysis of vedolizumab concentration from the pooled milk sample will be done by ELISA. Participants unable to return to the clinic may have their milk samples collected at home by a qualified and trained homecare nurse.

  • Concentration of Vedolizumab in Breast Milk on Day 8 [ Time Frame: Day 8 ] [ Designated as safety issue: No ]
    Milk from each breast will be completely emptied using an electric milk pump at the specified time point for the determination of vedolizumab concentrations in the milk. Analysis of vedolizumab concentration from the pooled milk sample will be done by ELISA. Participants unable to return to the clinic may have their milk samples collected at home by a qualified and trained homecare nurse.

  • Concentration of Vedolizumab in Breast Milk on Day 15 [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
    Milk from each breast will be completely emptied using an electric milk pump at the specified time point for the determination of vedolizumab concentrations in the milk. Analysis of vedolizumab concentration from the pooled milk sample will be done by ELISA. Participants unable to return to the clinic may have their milk samples collected at home by a qualified and trained homecare nurse.

  • Concentration of Vedolizumab in Breast Milk on Day 29 [ Time Frame: Day 29 ] [ Designated as safety issue: No ]
    Milk from each breast will be completely emptied using an electric milk pump at the specified time point for the determination of vedolizumab concentrations in the milk. Analysis of vedolizumab concentration from the pooled milk sample will be done by ELISA. Participants unable to return to the clinic may have their milk samples collected at home by a qualified and trained homecare nurse.

  • Concentration of Vedolizumab in Breast Milk on Day 57 [ Time Frame: Day 57 ] [ Designated as safety issue: No ]
    Milk from each breast will be completely emptied using an electric milk pump at the specified time point for the determination of vedolizumab concentrations in the milk. Analysis of vedolizumab concentration from the pooled milk sample will be done by ELISA.


Estimated Enrollment: 12
Study Start Date: October 2015
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vedolizumab
Vedolizumab 300 milligram (mg), intravenous (IV) infusion over 30-minutes, single dose on Day 1.
Drug: Vedolizumab
Vedolizumab intravenous infusion
Other Names:
  • Entyvio
  • MLN0002

Detailed Description:

The drug being tested in this study is called vedolizumab. This post-marketing milk-only lactation study will assess concentrations of vedolizumab in breast milk of lactating women with active UC or CD who are receiving vedolizumab therapeutically.

The study will enroll approximately 12 participants. All participants who received an established vedolizumab maintenance regimen (at least two 300 mg doses of vedolizumab once every 8 weeks prior to delivery of infant and one 300 mg dose of vedolizumab postpartum) will receive their scheduled dose of vedolizumab on day 1 of the study at the clinic, study site or other healthcare provider (HCP) office:

30-minute IV infusion of 300 mg vedolizumab. This multi-center trial will be conducted in the United States. The overall time to participate in this study is 3 months. Participants will make visits to clinic, study site or HCP office at Screening, Check-in (Day -1). Visits on Days 4, 8, 15, or 29. may be completed at the participant's home setting in the presence of a qualified nurse, or at a clinic, study site or other HCP office. The study exit/follow-up safety assessment will occur on Day 57(±3).

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

nclusion Criteria:

  1. Is capable of understanding and complying with protocol requirements.
  2. Signs and dates a 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 (received at least two 300 mg vedolizumab IV once every 8 weeks doses prior to the delivery of infant and one 300 mg once every 8 weeks dose of vedolizumab postpartum), 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 6 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.

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. Is expected to receive additional vedolizumab treatment between Day 2 and Study Exit/Follow-up (Day 57).

    4. Has received natalizumab treatment. 5. Has received any live vaccinations within 30 days prior to vedolizumab administration.

    6. Has a positive test result for hepatitis B surface antigen, antibody to hepatitis C virus, at Screening or a known history of human immunodeficiency virus infection (eg, common variable immunodeficiency, human immunodeficiency virus infection, organ transplantation).

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

    8. 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.

    9. 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.

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

    11. 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.

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

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

Has any of the following laboratory abnormalities during the Screening Period:

  • Hemoglobin level <8 g/dL.
  • White blood cell (WBC) count <3*10^9/L.
  • Lymphocyte count <0.5*10^9/L.
  • Platelet count <100×109/L or >1200*10^9/L.
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3*the upper limit of normal (ULN).
  • Alkaline phosphatase >3*ULN.
  • Serum creatinine >2*ULN.

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

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

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

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

    19. Has a prior history of difficulty establishing lactation. 20. Has a positive urine/blood drug result for drugs of abuse (defined as any illicit drug use) at Screening.

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

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

    23. Has an abnormal (clinically significant) electrocardiogram (ECG) at Screening. Entry of any participant with an abnormal (not clinically significant) ECG must be approved, and documented by signature by the principal investigator (PI) or delegate.

    24. Has an abnormal screening laboratory value that suggests a clinically significant underlying disease.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02559713

Contacts
Contact: Takeda Study Registration Call Center +1-866-835-2233 medicalinformation@tpna.com

Locations
United States, Colorado
Recruiting
Aurora, Colorado, United States
United States, Illinois
Not yet recruiting
Chicago, Illinois, United States
Not yet recruiting
Urbana, Illinois, United States
United States, New Jersey
Recruiting
Morristown, New Jersey, United States
United States, North Carolina
Recruiting
Chapel Hill, North Carolina, United States
United States, Tennessee
Recruiting
Nashville, Tennessee, United States
United States, Texas
Recruiting
Houston, Texas, United States
United States, Washington
Not yet recruiting
Seattle, Washington, United States
Sponsors and Collaborators
Takeda
Investigators
Study Director: Medical Director Takeda
  More Information

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02559713     History of Changes
Other Study ID Numbers: Vedolizumab-4001 
Study First Received: September 23, 2015
Last Updated: September 13, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Takeda:
Lactation
Lactating Women
Vedolizumab
Colitis Ulcerative
Crohn Disease
Crohn's

Additional relevant MeSH terms:
Vedolizumab
Crohn Disease
Colitis
Ulcer
Colitis, Ulcerative
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colonic Diseases
Pathologic Processes
Gastrointestinal Agents

ClinicalTrials.gov processed this record on September 30, 2016