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Enzyme Replacement Therapy

JR-141 for Hunter Syndrome

Phase 3

Waitlist Available

Research Sponsored by JCR Pharmaceuticals Co., Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up [a-1: week 157, 209, 261] [a-2: week 131, 157, 183, 209, 261] [a-3: week 131, 157, 209, 261 ] [a-4: week 131, 157, 183, 235, 287][b-1: week 78, 105, 157, 209, 261] [b-2: week 78, 105, 131, 157, 209, 261]

Awards & highlights

Study Summary

This trial will test a drug's safety and effectiveness to treat a rare genetic disorder.

Who is the study for?

This trial is for individuals with Hunter Syndrome who previously participated in the JR-141-GS31 study without safety concerns. They must be able to give consent or have a legal representative do so, agree to use effective contraception, and be capable of following the study protocol.Check my eligibility

What is being tested?

The trial is an extension study testing the long-term safety and effectiveness of JR-141 in treating Mucopolysaccharidosis Type II (Hunter Syndrome). It's open-label and multicenter, meaning everyone knows what treatment they're getting and it's conducted at multiple sites.See study design

What are the potential side effects?

While specific side effects are not listed here, participants will be monitored for any long-term safety issues related to the use of JR-141. This could include allergic reactions or other potential risks associated with ongoing treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ [a-1: week 157, 209, 261] [a-2: week 131, 157, 183, 209, 261] [a-3: week 131, 157, 209, 261 ] [a-4: week 131, 157, 183, 235, 287][b-1: week 78, 105, 157, 209, 261] [b-2: week 78, 105, 131, 157, 209, 261]

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~[a-1: week 157, 209, 261] [a-2: week 131, 157, 183, 209, 261] [a-3: week 131, 157, 209, 261 ] [a-4: week 131, 157, 183, 235, 287][b-1: week 78, 105, 157, 209, 261] [b-2: week 78, 105, 131, 157, 209, 261]

This trial's timeline: 3 weeks for screening, Varies for treatment, and [a-1: week 157, 209, 261] [a-2: week 131, 157, 183, 209, 261] [a-3: week 131, 157, 209, 261 ] [a-4: week 131, 157, 183, 235, 287][b-1: week 78, 105, 157, 209, 261] [b-2: week 78, 105, 131, 157, 209, 261] for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in heparan sulfate concentrations in cerebrospinal fluid from each subject's first administration of JR-141 throughout the Parent Study (JR-141-GS31) or this study to each time point

Change in neurocognitive testing, calculated by the BSID-III or KABC-II, from each subject's first administration of JR-141 throughout the Parent Study (JR-141-GS31) or this study

Change in neurocognitive testing, calculated by the VABS-II from each subject's first administration of JR-141 throughout the Parent Study (JR-141-GS31) or this study

+1 more

Secondary outcome measures

Change in 6-minute walk distance from each subject's first administration of JR-141 throughout the Parent Study (JR-141-GS31) or this study

Change in liver and spleen volume from each subject's first administration of JR-141 throughout the Parent Study (JR-141-GS31) or this study

Trial Design

1Treatment groups

Experimental Treatment

Group I: JR-141 2.0 mg/kg/weekExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

JR-141

2018

Completed Phase 3

~60

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

JCR Pharmaceuticals Co., Ltd.Lead Sponsor

11 Previous Clinical Trials

231 Total Patients Enrolled

Media Library

JR-141 (Enzyme Replacement Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05594992 — Phase 3

Hunter Syndrome Research Study Groups: JR-141 2.0 mg/kg/week

Hunter Syndrome Clinical Trial 2023: JR-141 Highlights & Side Effects. Trial Name: NCT05594992 — Phase 3

JR-141 (Enzyme Replacement Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05594992 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients able to join this research project at this time?

"Unfortunately, based on the information available on clinicaltrials.gov, this study is no longer searching for patients. Although this particular trial is completed, there are 30 other studies that are still looking for volunteers."

Answered by AI

Has the FDA greenlit JR-141 2.0 mg/kg/week for patient use?

"JR-141 2.0 mg/kg/week is estimated to be a safe drug by our team at Power, who gave it a score of 3. This is due in part because this medication has completed Phase 3 trials, meaning that there is some data supporting its efficacy as well as multiple rounds of data affirming its safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

An Extension Study of JR-141 to Evaluate the Long-term Safety and Efficacy in Mucopolysaccharidosis Type II (Hunter Syndrome) Subjects

2023. "An Extension Study of JR-141 to Evaluate the Long-term Safety and Efficacy in Mucopolysaccharidosis Type II (Hunter Syndrome) Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05594992.