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SCD-101 for Sickle Cell Disease

Phase 1

Waitlist Available

Led By John Muthu, MD

Research Sponsored by Invenux, LLC

Eligibility Criteria Checklist

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

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the time the participant is accessed at baseline through the final follow-up (18 weeks)

Awards & highlights

Study Summary

This trial will test if SCD-101 is safe and effective for adults with sickle cell disease.

Eligible Conditions

Sickle Cell Anemia
Sickle Cell Disease

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the time the participant is accessed at baseline through the final follow-up (18 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the time the participant is accessed at baseline through the final follow-up (18 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the time the participant is accessed at baseline through the final follow-up (18 weeks) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Determine the safety, tolerability, and dose limiting toxicities of escalating doses of SCD-101, assessed by frequency and severity of adverse events (AEs), and changes in vital signs, 12-lead ECGs and laboratory assessments as compared to baseline

Secondary outcome measures

Determine the effect of escalating doses of SCD-101 on the mean change from baseline in fatigue as measured by the PROMIS fatigue questionnaire

Determine the effect of escalating doses of SCD-101 on the mean change from baseline in functional capacity as measured by the 6-Minute Walk Test

Determine the effect of escalating doses of SCD-101 on the mean change from baseline in red blood cell hemolysis as measured by lactate dehydrogenase (LDH) and indirect bilirubin.

+3 more

Other outcome measures

Part B: Exploratory Outcome Measure the mean change from baseline in analgesic usage as measured by patient medication diary

Pain

Part B: Exploratory Outcome Measure the mean change from baseline in patient reported daily pain as measured by a Numeric Rating Scale (NRS 0-10)

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: SCD-101Experimental Treatment1 Intervention

SCD-101 dosed TID for 28-days

Group II: PlaceboPlacebo Group1 Intervention

Placebo dosed TID for 28-days

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Invenux, LLCLead Sponsor

State University of New York - Downstate Medical CenterOTHER

65 Previous Clinical Trials

12,491 Total Patients Enrolled

1 Trials studying Sickle Cell Anemia

159 Patients Enrolled for Sickle Cell Anemia

John Muthu, MDPrincipal InvestigatorKing's County Hospital

Media Library

SCD-101 (Not Available) Clinical Trial Eligibility Overview. Trial Name: NCT02380079 — Phase 1

Sickle Cell Anemia Research Study Groups: SCD-101, Placebo

Sickle Cell Anemia Clinical Trial 2023: SCD-101 Highlights & Side Effects. Trial Name: NCT02380079 — Phase 1

SCD-101 (Not Available) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02380079 — Phase 1

Frequently Asked Questions

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

Does my profile qualify me to partake in this investigation?

"Eligible patients for this trial will have to be between 18 and 55 years old, with a primary diagnosis of sickle cell anemia. In total, 60 people can join the investigation."

Answered by AI

What safety concerns have been raised about SCD-101?

"Given that this is a Phase 1 trial, implying limited data about the efficacy and safety of SCD-101, our team at Power has assigned it a score of 1."

Answered by AI

Are there any vacancies for potential participants in this medical research?

"According to clinicaltrials.gov data, this study is not currently recruiting patients; although it was initially posted on February 1st 2015 and last edited on February 19th 2021. Fortunately, there are 236 other trials that still require participants at the moment."

Answered by AI

Is this trial open to individuals aged seventy and above?

"To qualify for this research project, patients must be between 18 and 55 years old. For those younger than 18 or over 65, there are 159 studies and 99 studies respectively."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Dose-Escalation Study of SCD-101 in Sickle Cell Disease

2015. "Dose-Escalation Study of SCD-101 in Sickle Cell Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02380079.

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