The Mycophenolate Pregnancy Registry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-11-20

Study Completion Date

2026-12-31

Brief Summary

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The Mycophenolate Pregnancy Registry is designed as a prospective, observational registry collecting data regarding mycophenolate exposure during pregnancy, and pregnancy outcomes, fetal and infant outcomes after exposure. Early and later term pregnancy outcomes will be solicited at selected gestational time points. Structural and functional birth defects identified in the perinatal period through one year of life will be collected and classified.

This is a non-proprietary registry and is a component of a comprehensive pregnancy Risk Evaluation and Mitigation Strategy (REMS) plan required by the FDA for all mycophenolate-formulations, including CellCept, Myfortic and any generic formulations.

Detailed Description

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Conditions

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Heart Transplantation, Kidney Transplantation, Liver Transplantation, Autoimmune Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Pregnancy and reported maternal exposure to mycophenolate during pregnancy or within 6 weeks of discontinuing treatment

Exclusion Criteria

* Pregnancies for which there is paternal exposure only
* Pregnancies occurring outside the U.S.

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Genentech, Inc.

Locations

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Quintiles Outcome

Cambridge, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Reference Study ID Number: ML22679 https://forpatients.roche.com/

Role: CONTACT

Phone: 888-662-6728 (U.S. and Canada)

Email: [email protected]

Other Identifiers

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ML22679

Identifier Type: -

Identifier Source: org_study_id

The Mycophenolate Pregnancy Registry

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

Cohort

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Accord Healthcare, Inc.

Alkem Laboratories Ltd

Ascend Laboratories, LLC

Amneal Pharmaceuticals, LLC

Amta labs Limited

Apotex Corporation

Avet Lifesciences Limited

Azurity Pharmaceuticals

Biocon Pharma Limited

Concord Biotech Limited

Endo Pharmaceuticals

Hetero Labs Limited, Unit-V

Hikma Pharmaceuticals USA Inc.

Hisun Pharmaceuticals

Jubilant Cadista Pharmaceuticals, Inc.

Lannett Company, Inc.

Meitheal Pharmaceuticals, Inc.

Mylan Pharmaceuticals Inc

Novartis Pharmaceuticals

Rising Pharma Holdings, Inc.

RK Pharma Inc.

Sandoz

Strides Pharma, Inc

Teva Pharmaceuticals USA

TWi Pharmaceuticals, Inc.

VistaPharm, Inc.

Wuxi Fortune Pharmaceutical Co., Ltd

Zydus Pharmaceuticals