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Trial record 1 of 1 for:    NCT04056481
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Expanded Access Protocol of Givosiran for Patients With Acute Hepatic Porphyria

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04056481
Expanded Access Status : Available
First Posted : August 14, 2019
Last Update Posted : October 22, 2019
Information provided by (Responsible Party):
Alnylam Pharmaceuticals

Tracking Information
First Submitted Date August 12, 2019
First Posted Date August 14, 2019
Last Update Posted Date October 22, 2019
Descriptive Information
Brief Title Expanded Access Protocol of Givosiran for Patients With Acute Hepatic Porphyria
Brief Summary The purpose of this study is to provide expanded access of givosiran to patients with Acute Hepatic Porphyria (AHP).
Detailed Description Choosing to participate in an expanded access program is an important personal decision. Talk with your doctor and family members or friends about deciding to join a research study. To learn more about this study, please have your doctor contact the study research staff using the Contacts provided. For general information, see the link provided in More Information.
Study Type Expanded Access
Expanded Access Type Treatment IND/Protocol
Intervention Drug: Givosiran
givosiran (ALN-AS1) administered as a subcutaneous (SC) injection
Other Name: ALN-AS1
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Expanded Access Status Available
Contact: Alnylam EAP Hotline 1-877-256-9526
Listed Location Countries France,   United States
Removed Location Countries  
Administrative Information
NCT Number NCT04056481
Responsible Party Alnylam Pharmaceuticals
Study Sponsor Alnylam Pharmaceuticals
Collaborators Not Provided
Study Director: Mary-Jean Fanelli Alnylam Pharmaceuticals
PRS Account Alnylam Pharmaceuticals
Verification Date October 2019