Lonafarnib for Patients With Hutchinson-Gilford Progeria Syndrome or Progeroid Laminopathy
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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. |
ClinicalTrials.gov Identifier: NCT03895528 |
Expanded Access Status :
Available
First Posted : March 29, 2019
Last Update Posted : February 16, 2021
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Condition or disease | Intervention/treatment |
---|---|
Progeria HGPS | Drug: Lonafarnib |
Study Type : | Expanded Access |
Expanded Access Type : | Treatment IND/Protocol |
Official Title: | A Treatment IND (Investigational New Drug) Protocol for EAP (Expanded Access Program) for the Use of Lonafarnib in Patients With Hutchinson-Gilford Progeria Syndrome (HGPS) or Progeroid Laminopathy |

- Drug: Lonafarnib
Farnesyl transferase inhibitorOther Name: FTI

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Ages Eligible for Study: | 12 Months and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Inclusion Criteria:
- Clinical diagnosis of HGPS or progeroid laminopathy by qualified medical doctor (based on common phenotype as described in Gordon 2015 and Merideth 2008). Confirmation with genetic testing is preferred but not required.
- Adequate hepatic function as defined by SGPT (ALT) and SGOT (AST) ≤ 5 times upper limit of normal range for age
Exclusion Criteria:
- Taking medications or foods that are known to be moderate or strong inducers or inhibitors of CYP3A4 or sensitive CYP3A substrates; or if a patient is taking one of these drugs and cannot safely discontinue or take an alternative drug, the dose of the inhibitor/inducer must be adjusted per the treating physician
- Taking digoxin, a P-gp substrate with a narrow therapeutic window.
- Severe renal impairment (GFR < 30 mL/min/1.73m2).
- Uncontrolled infection.
- Presence of any active clinically relevant medical condition that in the opinion of the treating physician would preclude patient from safely participating in the program.
- Pregnant or breast-feeding or plan to become pregnant while on therapy.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03895528
Contact: Senior Director, Clinical Affairs | (650) 279-9845 | ProgeriaMA@eigerbio.com |
Responsible Party: | Eiger BioPharmaceuticals |
ClinicalTrials.gov Identifier: | NCT03895528 |
Other Study ID Numbers: |
EIG-EAP-LNF-001 |
First Posted: | March 29, 2019 Key Record Dates |
Last Update Posted: | February 16, 2021 |
Last Verified: | February 2021 |
Progeria Metabolism, Inborn Errors Genetic Diseases, Inborn Metabolic Diseases |
Lonafarnib Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |