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TerminatedNCT05438485JUMPUpdated Dec 27, 2023

Natural History Study of Patients With Methylmalonic Acidemia and Propionic Acidemia

An observational study in Methylmalonic Acidemia and Propionic Acidemia, sponsored by HemoShear Therapeutics. Terminated at 3 sites in 3 countries. Per ClinicalTrials.gov, last updated 2023-12-27.

Sponsored by HemoShear Therapeutics · Observational

Why this study was terminated
The decision to terminate the study was based on business considerations by the Sponsor.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
11
Sex
All
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Study summary

The JUMP (Journey to Understand MMA and PA) Study is being conducted by HemoShear Therapeutics and AllStripes, a rare disease online research platform. JUMP is designed to accelerate understanding of the natural course of methylmalonic acidemia (MMA) and propionic acidemia (PA) disease and treatment for families, researchers, clinicians and industry.

The study will collect and provide patient medical record information from multiple institutions for families to access in one place at no cost. AllStripes will remove identifying information like name and address from these medical records and aggregate this data for the HemoShear team to better understand the medical experience and progression of MMA and PA over time. In addition, academic researchers, healthcare practitioners and patient advocacy groups can apply to use the collective patient community data to answer specific research questions at no cost.

HemoShear is collecting natural history data on MMA and PA because the company needs insight into the real-world experience of many patients to better understand the disease and be able to scientifically demonstrate whether the potential new treatment they are developing is effective in improving outcomes.

This natural history study will include retrospective and prospective components. The retrospective component will consist of data abstracted from primarily electronic health records (eHR) and some paper records. The prospective component will include ongoing collection of medical records from enrolled participants, and participants may opt in to complete health-related questionnaires and an optional genetic testing sub-study.

After signing informed consent, participants or their legal guardians will grant permission to AllStripes to collect their health records for data abstraction.

Participants may opt into an optional no cost genetic testing sub-study. The JUMP (Journey to Understand MMA and PA) sub-study will help assess whether the genetic variant of the affected person may relate to disease severity and treatment response. Getting genetic testing will enable participants to understand the genetic mutation that causes their type of methylmalonic acidemia (MMA) or propionic acidemia (PA). Knowing the genetic mutations (whether from the MMUT, MMAA or MMAB gene or PCCA or PCCB) can help the impacted person, their caregivers and healthcare professionals understand the potential course of disease and select approaches to better manage the disease. The additional information will enable HemoShear and AllStripes to understand whether different genetic variants impact the disease journey and outcomes.

A separate informed consent will be obtained for participating in the sub-study.

02

Conditions studied

  • Methylmalonic Acidemia
  • Propionic Acidemia

Keywords

  • Methylmalonic Acidemia
  • Propionic Acidemia
  • Organic Acidemia
  • Inborn errors of metabolism
  • PCCA
  • PCCB
  • Propionyl-coenzyme A carboxylase
  • MMUT
  • Methylmalonyl-CoA mutase
  • Metabolic disease
  • Genetic disease
  • HemoShear
  • Natural History Study
  • JUMP
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In context

Methylmalonic acidemia

26 studies on the registry are indexed under Methylmalonic acidemia; 7 are open to participants now.

This study's enrollment of 11 is below the median of 30 across 11 observational studies indexed under Methylmalonic acidemia.

Browse Methylmalonic acidemia studies →

Lead sponsor

HemoShear Therapeutics is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Approximately 120 participants will be enrolled from the United States, Canada, and the United Kingdom.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Participant or participant's legal guardian must provide signed, informed eConsent/eAssent prior to releasing health records or performing any study-related procedures.
  2. Confirmed diagnosis of MMA or PA.
  3. Reside in the US, Canada, or United Kingdom and have all medical records available for abstraction.

Exclusion criteria

Exclusion Criteria:

  1. Participant or participant's legal guardian is unable to provide complete access to medical records.
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
11 participants (actual)
Target follow-up
12 Months
Patient registry
Yes

Groups and cohorts

  • Methylmalonic Acidemia (MMA)

    Approximately 60 subjects with Methylmalonic Acidemia

    Other: Registry

  • Propionic Acidemia (PA)

    Approximately 60 subjects with Propionic Acidemia

    Other: Registry

Interventions

  • OtherRegistry

    Observational (Registry)

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What researchers measure

Primary outcomes

  1. Understanding of the natural course of methylmalonic acidemia (MMA) and propionic acidemia (PA) disease and treatment for families, researchers, clinicians and industry.

    Time frame: 5 years

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Study locations

3 sites
  • AllStripes
    San Francisco, California 94551, United States
  • AllStripes
    Remote, Canada
  • AllStripes
    Remote, United Kingdom
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05438485
Lead sponsor
HemoShear Therapeutics
Collaborators
AllStripes Research Inc., Prometrika, LLC, Genome Medical
Responsible party
Sponsor
First posted
Jun 30, 2022
Start date
Aug 27, 2021
Primary completion
Oct 20, 2023
Completion
Oct 20, 2023
Last update
Dec 27, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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