Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04628871
Other study ID # ST-IVPRP-LT01
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date November 3, 2020
Est. completion date January 1, 2030

Study information

Verified date May 2024
Source Sangamo Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Long-term follow-up of subjects who received SB-318, SB-913, or SB-FIX in a previous trial and completed at least 52 weeks post-infusion follow-up in their primary protocol. Enrolled subjects will be followed for a total of up to 10 years following exposure to SB-318, SB-913, or SB-FIX.


Description:

Non-interventional, multi-center, long-term follow-up (LTFU) study of subjects dosed with SB-318 in the clinical study SB-318-1502, SB-913 in the clinical study SB-913-1602, and SB-FIX in clinical study SB-FIX-1501. All subjects dosed in the studies and completed at least 52 weeks post-infusion follow-up in their primary protocol will be offered to participate. Subjects who enroll will be monitored for a total of up to 10 years following exposure to the respective investigational products.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 13
Est. completion date January 1, 2030
Est. primary completion date January 1, 2030
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Subjects who received SB-318 under Study Protocol SB-318-1502, SB-913 under Study Protocol SB-913-1602, or SB-FIX under Study Protocol SB-FIX-1501 2. Subjects who have provided consent to participate in the LTFU study. Exclusion Criteria: 1. Unable to comply with study visit schedule or study visit procedures. 2. Any other reason that, in the opinion of the Investigator or Medical Monitor, would render the subject unsuitable for participation in the study.

Study Design


Intervention

Biological:
SB-318
No study drug is administered in this study. Subject who received SB-318 in a previous trial will be evaluated in this trial for long-term safety.
SB-913
No study drug is administered in this study. Subject who received SB-913 in a previous trial will be evaluated in this trial for long-term safety.
SB-FIX
No study drug is administered in this study. Subject who received SB-FIX in a previous trial will be evaluated in this trial for long-term safety.

Locations

Country Name City State
United States University of North Carolina Chapel Hill North Carolina
United States Ann & Robert H. Lurie Children's Hospital of Chicago Chicago Illinois
United States Cincinnati Children's Hospital Medical Center Cincinnati Ohio
United States New York University Grossman School of Medicine New York New York
United States UCSF Benioff Children's Hospital Oakland Oakland California

Sponsors (1)

Lead Sponsor Collaborator
Sangamo Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Long-term safety Long-term safety of SB-318, SB-913, and SB-FIX by assessment of any newly-diagnosed or worsening of existing medical conditions. 10 years
See also
  Status Clinical Trial Phase
Completed NCT04072237 - Study of Coagulation Faction VIIa Variant Marzeptacog Alfa (Activated) in Adult Subjects With Hemophilia Phase 1
Completed NCT02199717 - An Institutional Pilot Study to Investigate Physical Activity Patterns in Boys With Hemophilia N/A
Completed NCT01662531 - A Safety, Efficacy and Pharmacokinetics Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Children With Hemophilia B Phase 3
Completed NCT01335061 - Study To Compare On-Demand Treatment To A Prophylaxis Regimen Of BeneFIX In Subjects With Moderately Severe to Severe Hemophilia B Phase 3
Completed NCT01217255 - Comparing the Burden of Illness of Hemophilia in the Developing and the Developed World
Completed NCT00037557 - Study Evaluating rFIX; BeneFIX in Severe Hemophilia B Phase 3
Completed NCT02554773 - An Open-label Extension Study of an Investigational Drug, Fitusiran, in Patients With Moderate or Severe Hemophilia A or B Phase 1/Phase 2
Terminated NCT02807753 - The Hemophilia Ultrasound Project
Active, not recruiting NCT03901755 - An International Study to Evaluate the Real-world Effectiveness and Usage of Alprolix in Patients With Haemophilia B
Not yet recruiting NCT05980377 - Patterns of Hemophilia Care in Assiut Children Patients
Recruiting NCT05687474 - Baby Detect : Genomic Newborn Screening
Terminated NCT03248141 - Understanding Hemophilia A and B Drug Dosage Administration Patterns
Terminated NCT01460147 - Osteoporosis and MRI Study in Hemophilia N/A
Completed NCT03818529 - ATHN 8: Previously Untreated Patients (PUPs) Matter Study
Completed NCT02571569 - A Single Escalating Dose and Multiple Dose Study of BAY 1093884 in Subjects With Severe Hemophilia Types A or B, With or Without Inhibitors Phase 1
Terminated NCT01620801 - Hemophilia B Gene Therapy With AAV8 Vector Phase 1
Completed NCT01233440 - Safety and Pharmacokinetic Study of a Recombinant Coagulation Factor IX Albumin Fusion Protein in Subjects With Hemophilia B Phase 1
Active, not recruiting NCT04135300 - Gene Therapy for Chinese Hemophilia B N/A
Enrolling by invitation NCT03655223 - Early Check: Expanded Screening in Newborns
Terminated NCT00947193 - Study of Ataluren (PTC124) in Hemophilia A and B Phase 2