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NCT Number: NCT01733082

The Mycophenolate Pregnancy Registry

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.

Recruiting

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Key information

Conditions

Heart Transplantation, Kidney Transplantation, Liver Transplantation, Autoimmune Diseases Autoimmune Diseases Immune System Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Quintiles Outcome

Cambridge, Massachusetts, 02139, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Maternal Outcomes: Incidence of Pregnancy Complications

    Time frame: Approximately 13 years

  2. Fetal Outcomes: Incidence of Congenital Disorders

    Time frame: Approximately 13 years

  3. Time/Duration of Mycophenolate Exposure

    Time frame: Approximately 13 years

  4. Mycophenolate Dose/Regimen

    Time frame: Approximately 13 years

  5. Indications for Mycophenolate use

    Time frame: Approximately 13 years

  6. Maternal Medical/Demographic Characteristics

    Time frame: Approximately 13 years

Secondary outcomes

  1. Occurrence of Educational Counseling on the Increased Risks of Birth Defects With Mycophenolate Therapy

    Time frame: Approximately 13 years

Study contacts

Contact information is provided by the study sponsor or research team.

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

CONTACT

Reference Study ID Number: ML22679 https://forpatients.roche.com/ No attachments to email below.

CONTACT

[email protected]

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

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Collaborators

  • Accord Healthcare, Inc.
  • Alkem Laboratories Ltd
  • Amneal Pharmaceuticals, LLC
  • Amta labs Limited
  • Apotex Inc.
  • Ascend Laboratories, LLC
  • Avet Lifesciences Limited
  • Azurity Pharmaceuticals
  • Biocon Pharma Limited
  • Concord Biotech Limited
  • Endo USA Inc., a Keenova Therapeutics Company
  • 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
  • RK Pharma Inc.
  • Rising Pharma Holdings, Inc.
  • Sandoz
  • Strides Pharma, Inc
  • TWi Pharmaceuticals, Inc.
  • Teva Pharmaceuticals USA
  • VistaPharm, Inc.
  • Wuxi Fortune Pharmaceutical Co., Ltd
  • Zydus Pharmaceuticals

Registry information

Important dates

Study start
2012
Primary completion
2040
Study completion
2040
First posted
Nov 26, 2012
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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