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Clinical Trials/NL-OMON50391
NL-OMON50391
Completed
Phase 2

A Phase 2, Multicenter, Open-Label, Extension Study to Evaluate the Long-Term Administration of ALN-GO1 in Patients with Primary Hyperoxaluria Type 1. - ALN-GO102

Alnylam Pharmaceuticals, Inc0 sites2 target enrollmentTBD
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ConditionsPrimary Hyperoxaluria Type 1metabolic disorders10038430

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Primary Hyperoxaluria Type 1
Sponsor
Alnylam Pharmaceuticals, Inc
Enrollment
2
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

Trial is onging in other countries

Registry
who.int
Start Date
TBD
End Date
December 2, 2022
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
Alnylam Pharmaceuticals, Inc

Eligibility Criteria

Inclusion Criteria

  • •1\. Enrollment within 12 months of completion of Study ALN\-GO1\-001 and in the
  • •opinion of the investigator, tolerated the study drug
  • •2\. If taking vitamin B6 (pyridoxine), willing to remain on a stable regimen for
  • •the study duration
  • •3\. Women of child\-bearing potential must have a negative pregnancy test, cannot
  • •be breast feeding, and must be willing to use a highly effective method of
  • •contraception from 14 days before first dose and throughout study participation
  • •until the completion of the follow\-up period.
  • •4\. Willing and able to comply with the study requirements and to provide
  • •written informed consent and assent in the case of patients under the age of

Exclusion Criteria

  • •1\. Any uncontrolled or serious disease, or any medical or surgical condition
  • •(with the exception of PH1\) that may either interfere with participation in the
  • •clinical study, and/or put the patient significant risk (according to the
  • •Investigator\*s judgment) if he/she participates in the clinical study
  • •2\. An underlying known disease or surgical or medical condition (with the
  • •exception of PH1\) that in the opinion of the investigator might interfere with
  • •the interpretation of the clinical study results
  • •3\. Requirement for chronic dialysis
  • •4\. Triplicate 12\-lead ECG with clinically significant abnormalities at Baseline
  • •visit, at the discretion of the investigator

Outcomes

Primary Outcomes

Not specified

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