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Japanese study checks safety of gaucher drug VPRIV in Real-World use

NCT ID NCT03625882

Disease control Sponsor: Takeda Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed study in Japan looked at the safety and effectiveness of the drug VPRIV (velaglucerase alfa) in 63 people with Gaucher disease. Participants were either new to treatment or switching from another Gaucher therapy. The main goal was to track side effects and serious side effects, while also measuring changes in hemoglobin levels. Because this is an observational survey, it helps confirm how the drug works in everyday medical practice.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
velaglucerase alfa (VPRIV)
What this could lead to
If results are positive, this could confirm that VPRIV is a safe and effective option for managing Gaucher disease in Japanese patients.
What could go wrong
This is an observational survey, not a controlled trial, so it cannot prove cause and effect. The small size (63 people) and single-country setting may limit how well the findings apply elsewhere.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

63 people

The number who actually took part.

Started

Sep 2014

Finished

May 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Participants with confirmed Gaucher disease (types 1, 2, or 3) irrespective of any age or gender who are either naïve to treatment or participants that have been treated with another therapeutic agent for Gaucher disease.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or female participants with a confirmed diagnosis of Gaucher disease * Participants who are either naïve to treatment or participants that have been treated with another therapeutic agent for Gaucher disease * Participants who start VPRIV treatment or transition from VPRIV clinical studies during the enrollment period Exclusion Criteria: \-

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Conditions

The condition(s) this trial relates to.

Gaucher disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gaucher disease

Contacts and locations

Locations

  • Chiba

    Chiba, 266-0007, Japan

  • Fukuyama

    Fukuyama, Hiroshima, 721-0927, Japan

  • Gifu

    Gifu, 500-8212, Japan

  • Hamamatsu

    Hamamatsu, Shizuoka, 431-3125, Japan

  • Hamamatsu

    Hamamatsu, Shizuoka, 434-8511, Japan

  • Higashihiroshima

    Higashihiroshima, Hiroshima, 739-0041, Japan

  • Hiroshima

    Hiroshima, 730-0046, Japan

  • Hiroshima

    Hiroshima, 734-0037, Japan

  • Iwata

    Iwata, Shizuoka, 438-0002, Japan

  • Kagoshima

    Kagoshima, 892-0853, Japan

  • Kawagoe

    Kawagoe, Saitama, 350-8550, Japan

  • Kitakyushu

    Kitakyushu, Fukuoka, 802-0803, Japan

  • Konan

    Kōnan, Aichi-ken, 483-8704, Japan

  • Kumamoto

    Kumamoto, 860-8556, Japan

  • Kurume

    Kurume, Fukuoka, 830-0011, Japan

  • Kyoto

    Kyoto, 606-8507, Japan

  • Matsue

    Matsue, Shimane, 690-0864, Japan

  • Minato

    Minato, Tokyo, 105-8471, Japan

  • Moriyama

    Moriyama, Shiga, 524-0022, Japan

  • Nagoya

    Nagoya, Aichi-ken, 453-0801, Japan

  • Obihiro

    Obihiro, Hokkaido, 080-0016, Japan

  • Okayama

    Okayama, 701-1192, Japan

  • Osaka

    Osaka, 534-0021, Japan

  • Osaka

    Osaka, 545-8586, Japan

  • Osaka

    Osaka, 553-0003, Japan

  • Otsu

    Ōtsu, Shiga, 520-2192, Japan

  • Sagamihara

    Sagamihara, Kanagawa, 252-0375, Japan

  • Saitama

    Saitama, 339-8551, Japan

  • Sendai

    Sendai, Miyagi, 980-8574, Japan

  • Shizuoka

    Shizuoka, 420-8688, Japan

  • Suita

    Suita, Osaka, 565-0871, Japan

  • Sumida-ku

    Sumida-ku, Tokyo, 130-0005, Japan

  • Tokorozawa

    Tokorozawa, Saitama, 359-8513, Japan

  • Tondabayashi

    Tondabayashi, Osaka, 584-0000, Japan

  • Yonago

    Yonago, Tottori, 683-8504, Japan

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