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An Extension Study of an Investigational Drug, ALN-GO1, in Patients With Primary Hyperoxaluria Type 1

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ClinicalTrials.gov Identifier: NCT03350451
Recruitment Status : Enrolling by invitation
First Posted : November 22, 2017
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
Alnylam Pharmaceuticals

November 17, 2017
November 22, 2017
December 12, 2018
November 20, 2017
September 2021   (Final data collection date for primary outcome measure)
Proportion of subjects experiencing adverse events [ Time Frame: Up to 850 days ]
Same as current
Complete list of historical versions of study NCT03350451 on ClinicalTrials.gov Archive Site
  • Change in urinary oxalate excretion over time [ Time Frame: Up to 834 days ]
  • Change in estimated glomerular filtration rate (eGFR) over time [ Time Frame: through Day 834 ]
  • Change in measured creatinine clearance (mCrCl) over time [ Time Frame: through Day 834 ]
Same as current
Not Provided
Not Provided
 
An Extension Study of an Investigational Drug, ALN-GO1, in Patients With Primary Hyperoxaluria Type 1
A Phase 2, Multicenter, Open-Label, Extension Study to Evaluate the Long-Term Administration of ALN-GO1 in Patients With Primary Hyperoxaluria Type 1
The purpose of this study is to evaluate the long-term safety and tolerability of ALN-GO1 in patients with Primary Hyperoxaluria Type 1.
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • PH1
  • Primary Hyperoxaluria
  • RNAi Therapeutic
  • siRNA
  • AGT
Drug: ALN-GO1
Multiple doses of ALN-GO1 by subcutaneous (sc) injection
Experimental: Lumasiran (ALN-GO1)
Intervention: Drug: ALN-GO1
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
24
Same as current
September 2021
September 2021   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Enrollment within 12 months of completion of Study ALN-GO1-001
  • In the opinion of the investigator tolerated the study drug
  • If taking Vitamin B6 (pyridoxine), willing to remain on a stable regimen for the study duration
  • 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
  • Willing to provide written informed consent and to comply with study requirements

Exclusion Criteria:

  • Clinically significant health concerns (with the exception of PH1)
  • Clinically significant cardiovascular abnormality
  • Abnormal for AST/ALT and any other clinical safety laboratory result considered clinically significant
  • Requirement for chronic dialysis
Sexes Eligible for Study: All
6 Years and older   (Child, Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
France,   Germany,   Israel,   Netherlands,   United Kingdom
 
 
NCT03350451
ALN-GO1-002
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Alnylam Pharmaceuticals
Alnylam Pharmaceuticals
Not Provided
Study Director: Tracy McGregor, MD, MSCI Alnylam Pharmaceuticals
Alnylam Pharmaceuticals
December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP