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A Phase 1 Study of Givosiran (ALN-AS1) in Patients With Acute Intermittent Porphyria (AIP)

NCT02452372 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-06-14

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and tolerability of givosiran (ALN-AS1) in AIP patients as well as to characterize pharmacokinetics (PK) and pharmacodynamics (PD) of ALN-AS1 in AIP patients.

Conditions

  • Acute Intermittent Porphyria

Interventions

DRUG

givosiran (ALN-AS1)

Single or multiple doses of ALN-AS1 by subcutaneous (sc) injection

DRUG

Sterile Normal Saline (0.9% NaCl)

calculated volume to match active comparator

Sponsors & Collaborators

Principal Investigators

  • Amy Simon, MD · Alnylam Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-06
Primary Completion
2017-09-06
Completion
2017-09-06

Countries

  • United States
  • Sweden
  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02452372 on ClinicalTrials.gov