Essential Thrombocythemia (ET)NCT03625895

Agrylin Drug Use-Result Survey

An observational study of Essential Thrombocythemia (ET), run by Takeda at 488 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The objective of this survey is to collect data to evaluate the safety and efficacy of anagrelide hydrochloride in the post-marketing phase in participants diagnosed with Essential Thrombocythemia (ET). Read more about this study

Who is it for?: Any age
Conditions the study is for: Essential Thrombocythemia (ET)
How many people: 1,826 participants
Where: 488 sitesJapan
Study dates: 25 Nov 2014to 11 Mar 2021
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Participants with essential thrombocythemia (ET) being treated with agrylin will be evaluated for this study.

Who may be able to join

All cases who received treatment with Agrylin.

Who cannot join

Trial locations and contacts

488 sites in 1 country.

City, postcode or hospital

300 sites in 1 country

Japan300 sites

Adachi-ku
Adachi-ku, Tokyo, 123-0864
Akashi-city
Akashi, Hyōgo, 673-0021
Aki-city
Aki, Kochi, 784-0027
Akishima-city
Akishima, Tokyo, 196-0015
Akita-city
Akita, Akita, 010-0012
Akita-city
Akita, Akita, 010-0852
Akita-city
Akita, Akita, 010-0933
Akita-city
Akita, Akita, 011-0948
Ako-city
Ako, Hyōgo, 678-0241
Amagasaki-city
Amagasaki, Hyōgo, 660-0892
Amagasaki-city
Amagasaki, Hyōgo, 661-0976
Amakusa-city
Amakusa, Kumamoto, 863-0046
Annaka-city
Annaka, Gunma, 379-0133
Aomori-city
Aomori, Aomori, 030-0913
Arao-city
Arao, Kumamoto, 864-0041
Arida-gun
Arida-gun, Wakayama, 643-0034
Asahi-city
Asahi, Chiba, 289-2511
Asahikawa-city
Asahikawa, Hokkaido, 070-0029
Asahikawa-city
Asahikawa, Hokkaido, 070-0061
Asahikawa-city
Asahikawa, Hokkaido, 078-8211
Asahikawa-city
Asahikawa, Hokkaido, 078-8802
Asakura-gun
Asakura-gun, Fukuoka, 838-0815
Ashikaga-city
Ashikaga, Tochigi, 326-0822
Bungotakada-city
BungoTakada, Oita Prefecture, 879-0627
Bunkyo-ku
Bunkyo-ku, Tokyo, 113-0021
Bunkyo-ku
Bunkyo-ku, Tokyo, 113-0022
Bunkyo-ku
Bunkyo-ku, Tokyo, 113-0033
Bunkyo-ku
Bunkyo-ku, Tokyo, 113-0034
Chiba-city
Chiba, Chiba, 260-0026
Chiba-city
Chiba, Chiba, 260-0027
Chiba-city
Chiba, Chiba, 260-0801
Chiba-city
Chiba, Chiba, 260-0842
Chiba-city
Chiba, Chiba, 260-0856
Chiba-city
Chiba, Chiba, 263-0002
Chichibu-city
Chichibu, Saitama, 368-0051
Chigasaki-city
Chigasaki, Kanagawa, 253-0053
Chitose-city
Chitose, Hokkaido, 066-0042
Chiyoda-ku
Chiyoda-ku, Tokyo, 101-0024
Chiyoda-ku
Chiyoda-ku, Tokyo, 102-0071
Chofu-city
Chōfu, Tokyo, 182-0026
Chuo-ku
Chuo-ku, Tokyo, 104-0044
Date-city
Date, Fukushima, 960-0502
Ebina-city
Ebina, Kanagawa, 243-0433
Edogawa-ku
Edogawa-ku, Tokyo, 133-0052
Fuchu-city
Fuchū, Tokyo, 183-0042
Fujieda-city
Fujieda, Shizuoka, 426-0077
Fujioka-city
Fujioka, Gunma, 375-0024
Fujisawa-city
Fujisawa, Kanagawa, 251-0054
Fukaya-city
Fukaya, Saitama, 366-0052
Fukuchiyama-city
Fukuchiyama, Kyoto, 620-0056
Fukui-city
Fukui-shi, Fukui, 910-0017
Fukui-city
Fukui-shi, Fukui, 910-0846
Fukui-city
Fukui-shi, Fukui, 918-8011
Fukuoka-city
Fukuoka, Fukuoka, 810-0062
Fukuoka-city
Fukuoka, Fukuoka, 810-0065
Fukuoka-city
Fukuoka, Fukuoka, 811-1347
Fukuoka-city
Fukuoka, Fukuoka, 812-0033
Fukuoka-city
Fukuoka, Fukuoka, 812-0054
Fukuoka-city
Fukuoka, Fukuoka, 813-0044
Fukuoka-city
Fukuoka, Fukuoka, 814-0006
Fukuoka-city
Fukuoka, Fukuoka, 814-0133
Fukushima-city
Fukushima, Fukushima, 960-1101
Fukushima-city
Fukushima, Fukushima, 960-1247
Fukushima-city
Fukushima, Fukushima, 960-8163
Fukuyama-city
Fukuyama, Hiroshima, 720-0001
Fukuyama-city
Fukuyama, Hiroshima, 729-3103
Funabashi-city
Funabashi, Chiba, 273-0021
Funabashi-city
Funabashi, Chiba, 274-0065
Furano-city
Furano, Hokkaido, 076-0038
Gamagori-city
Gamagōri, Aichi-ken, 443-0004
Gifu-city
Gifu, Gifu, 500-8226
Gifu-city
Gifu, Gifu, 500-8822
Gifu-city
Gifu, Gifu, 501-1112
Gifu-city
Gifu, Gifu, 502-0844
Gobo-city
Gobō, Wakayama, 644-0002
Gotsu-city
Gōtsuchō, Shimane, 695-0011
Gujo-city
Gujō, Gifu, 501-4228
Hachinohe-city
Hachinohe, Aomori, 031-0822
Hachinohe-city
Hachinohe, Aomori, 039-1104
Hachioji-city
Hachiōji, Tokyo, 192-0071
Hakodate-city
Hakodate, Hokkaido, 040-0025
Hakodate-city
Hakodate, Hokkaido, 041-0821
Hamada-city
Hamada, Shimane, 697-0022
Hamada-city
Hamada, Shimane, 697-0062
Hamamatsu-city
Hamamatsu, Shizuoka, 430-0906
Hamamatsu-city
Hamamatsu, Shizuoka, 430-0929
Hamamatsu-city
Hamamatsu, Shizuoka, 432-8002
Handa City
Handa, Aichi-ken, 475-0817
Hasuda-city
Hasuda, Saitama, 349-0131
Hekinan-city
Hekinan, Aichi-ken, 447-0084
Higashihiroshima-city
Higashihiroshima, Hiroshima, 739-0041
Higashiibaraki-gun
Higashiibaraki-gun, Ibaraki, 311-3117
Higashimuro-gun
Higashimuro-gun, Wakayama, 649-5331
Higashiosaka-city
Higashiosaka, Osaka, 577-0801
Himeji-city
Himeji, Hyōgo, 670-0012
Himeji-city
Himeji, Hyōgo, 670-0063
Himeji-city
Himeji, Hyōgo, 671-1122
Hirakata-city
Hirakata, Osaka, 573-0153
Hiroshima-city
Hiroshima, Hiroshima, 730-0037
Hiroshima-city
Hiroshima, Hiroshima, 731-5134
Hitachi-city
Hitachi, Ibaraki, 317-0077
Hitachinaka-city
Hitachi-Naka, Ibaraki, 312-0057
Hofu-city
Hōfu, Yamaguchi, 747-0065
Ichihara-city
Ichihara, Chiba, 290-0003
Ichihara-city
Ichihara, Chiba, 299-0111
Ichikawa-city
Ichikawa, Chiba, 272-0824
Ichinomiya-city
Ichinomiya, Aichi-ken, 491-0036
Ichinomiya-city
Ichinomiya, Aichi-ken, 491-0041
Ichinomiya-city
Ichinomiya, Aichi-ken, 491-0859
Iizuka-city
Iizuka, Fukuoka, 820-0018
Ikeda-city
Ikeda, Osaka, 563-0025
Iki-city
Iki, Nagasaki, 811-5135
Ikoma-city
Ikoma, Nara, 630-0227
Inashiki-gun
Inashiki-gun, Ibaraki, 300-0415
Inzai-city
Inzai, Chiba, 270-1613
Iruma-gun
Iruma-gun, Saitama, 350-0451
Isahaya-city
Isahaya, Nagasaki, 854-0071
Ise-city
Ise, Mie-ken, 516-0008
Ise-city
Ise, Mie-ken, 516-0014
Isehara-city
Isehara, Kanagawa, 259-1142
Isehara-city
Isehara, Kanagawa, 259-1143
Ishioka-city
Ishioka, Ibaraki, 315-0023
Itabashi-ku
Itabashi-ku, Tokyo, 173-0003
Itabashi-ku
Itabashi-ku, Tokyo, 173-0015
Itabashi-ku
Itabashi-ku, Tokyo, 174-0051
Itami-city
Itami, Hyōgo, 664-8540
Itano-gun
Itano-gun, Tokushima, 771-0204
Itoigawa-city
Itoigawa, Niigata, 941-0006
Iwata-city
Iwata, Shizuoka, 438-8550
Izumiootsu-city
Izumiootsu-city, Osaka, 595-0072
Izumiotsu-city
Izumiōtsu, Osaka, 595-0006
Izumisano-city
Izumisano, Osaka, 598-0048
Izumo-city
Izumo, Shimane, 693-0021
Izumo-city
Izumo, Shimane, 693-0068
Izunokuni-city
Izunokuni, Shizuoka, 410-2211
Joetsu-city
Jōetsu, Niigata, 943-0147
Kagoshima-city
Kagoshima, Kagoshima-ken, 890-0063
Kagoshima-city
Kagoshima, Kagoshima-ken, 890-0075
Kagoshima-city
Kagoshima, Kagoshima-ken, 892-0853
Kahoku-gun
Kahoku-gun, Ishikawa-ken, 920-0265
Kaizuka-city
Kaizuka, Osaka, 597-0015
Kamakura-city
Kamakura, Kanagawa, 247-0056
Kamakura-city
Kamakura, Kanagawa, 247-0072
Kamogawa-city
Kamogawa, Chiba, 296-0041
Kanonji-city
Kan’onjichō, Kagawa-ken, 769-1601
Kanazawa-city
Kanazawa, Ishikawa-ken, 920-0001
Kanazawa-city
Kanazawa, Ishikawa-ken, 920-0848
Kanazawa-city
Kanazawa, Ishikawa-ken, 920-0934
Kanazawa-city
Kanazawa, Ishikawa-ken, 920-8201
Kani-city
Kani, Gifu, 509-0206
Kasai-city
Kasai, Hyōgo, 675-2311
Kasama-city
Kasama, Ibaraki, 309-1703
Kashiwa-city
Kashiwa, Chiba, 277-0004
Kashiwazaki-city
Kashiwazaki, Niigata, 945-0035
Kashiwazaki-city
Kashiwazaki, Niigata, 945-0847
Kasuga-city
Kasuga, Fukuoka, 816-0864
Katsushika-ku
Katsushika-ku, Tokyo, 124-0006
Katsushika-ku
Katsushika-ku, Tokyo, 125-0061
Kawachinagano-city
Kawachi-Nagano, Osaka, 586-0008
Kawachinagano-city
Kawachi-Nagano, Osaka, 586-0017
Kawagoe-city
Kawagoe, Saitama, 350-0844
Kawaguchi-city
Kawaguchi, Saitama, 333-0831
Kawaguchi-city
Kawaguchi, Saitama, 333-0833
Kawasaki-city
Kawasaki, Kanagawa, 210-0024
Kawasaki-city
Kawasaki, Kanagawa, 210-0802
Kawasaki-city
Kawasaki, Kanagawa, 211-0021
Kawasaki-city
Kawasaki, Kanagawa, 215-0026
Kawasaki-city
Kawasaki, Kanagawa, 216-0015
Kisarazu-city
Kisarazu, Chiba, 292-0822
Kisarazu-city
Kisarazu, Chiba, 292-0832
Kishiwada-city
Kishiwada, Osaka, 596-0042
Kishiwada-city
Kishiwada, Osaka, 596-0822
Kitaadachi-gun
Kitaadachi-gun, Saitama, 362-0806
Kitaazumi-gun
Kitaazumi-gun, Nagano, 399-8601
Kitakami-city
Kitakami, Iwate, 024-0091
Kitakyushu-city
Kitakyushu, Fukuoka, 802-0001
Kitakyushu-city
Kitakyushu, Fukuoka, 803-0816
Kitakyushu-city
Kitakyushu, Fukuoka, 806-0034
Kitakyushu-city
Kitakyushu, Fukuoka, 807-0804
Kobe-city
Kobe, Hyōgo, 650-0047
Kobe-city
Kobe, Hyōgo, 651-0072
Kobe-city
Kobe, Hyōgo, 652-0863
Kobe-city
Kobe, Hyōgo, 657-0064
Kochi-city
Kochi, Kochi, 780-0051
Kochi-city
Kochi, Kochi, 780-0062
Kochi-city
Kochi, Kochi, 780-8077
Kofu-city
Kofu, Yamanashi, 400-0016
Kofu-city
Kofu, Yamanashi, 400-0027
Koga-city
Koga, Fukuoka, 811-3113
Koga-city
Koga, Ibaraki, 306-0014
Koga-city
Koga, Ibaraki, 306-0232
Koganei-city
Koganei, Tokyo, 184-0004
Komaki-city
Komaki, Aichi-ken, 485-0044
Komatsu-city
Komatsu, Ishikawa-ken, 923-0961
Koshigaya-city
Koshigaya, Saitama, 343-0845
Kumamoto-city
Kumamoto, Kumamoto, 860-0816
Kumamoto-city
Kumamoto, Kumamoto, 861-8039
Kumamoto-city
Kumamoto, Kumamoto, 862-0975
Kumano-city
Kumano, Mie-ken, 519-4324
Kunigami-gun
Kunigami-gun, Okinawa, 905-0414
Kurashiki-city
Kurashiki, Okayama-ken, 701-0114
Kurashiki-city
Kurashiki, Okayama-ken, 710-0052
Kurashiki-city
Kurashiki, Okayama-ken, 710-0824
Kure-city
Kure, Hiroshima, 737-0023
Kurobe-city
Kurobe-shi, Toyama, 938-0031
Kurume-city
Kurume, Fukuoka, 830-0011
Kurume-city
Kurume, Fukuoka, 830-0047
Kushiro-city
Kushiro, Hokkaido, 085-0052
Kuwana-city
Kuwana, Mie-ken, 511-0061
Kuwana-city
Kuwana, Mie-ken, 511-0819
Kyoto-city
Kyoto, Kyoto, 601-1434
Kyoto-city
Kyoto, Kyoto, 602-8026
Kyoto-city
Kyoto, Kyoto, 602-8566
Kyoto-city
Kyoto, Kyoto, 603-8151
Kyoto-city
Kyoto, Kyoto, 604-8845
Kyoto-city
Kyoto, Kyoto, 605-0981
Kyoto-city
Kyoto, Kyoto, 606-8317
Kyoto-city
Kyoto, Kyoto, 607-8062
Kyoto-city
Kyoto, Kyoto, 607-8086
Kyoto-city
Kyoto, Kyoto, 612-0861
Kyoto-city
Kyoto, Kyoto, 615-0031
Kyoto-city
Kyoto, Kyoto, 615-8256
Maebashi-city
Maebashi, Gunma, 371-0034
Maebashi-city
Maebashi, Gunma, 371-0821
Maebashi-city
Maebashi, Gunma, 379-2115
Maizuru-city
Maizuru, Kyoto, 625-0036
Maniwa-city
Maniwa, Okayama-ken, 719-3105
Masuda-city
Masuda, Shimane, 698-0003
Matsudo-city
Matsudo, Chiba, 270-0034
Matsudo-city
Matsudo, Chiba, 271-0064
Matsue-city
Matsue, Shimane, 690-0886
Matsumoto-city
Matsumoto, Nagano, 399-0021
Matsusaka-city
Matsusaka, Mie-ken, 515-0003
Matsuyama-city
Matsuyama, Ehime, 790-0024
Matsuyama-city
Matsuyama, Ehime, 790-0826
Meguro-ku
Meguro-ku, Tokyo, 153-0062
Mihara-city
Mihara, Hiroshima, 723-0014
Minamisatsuma-city
Minamisatsuma, Kagoshima-ken, 897-1123
Minamisoma-city
Minamisoma-city, Fukushima, 975-0033
Minamiuonuma-city
Minamiuonuma, Niigata, 949-7302
Minato-ku
Minato-ku, Tokyo, 105-0003
Minato-ku
Minato-ku, Tokyo, 108-0073
Mino-city
Mino-city, Osaka, 562-0014
Minokamo-city
Minokamo, Gifu, 505-0034
Mishima-city
Mishima, Shizuoka, 411-0817
Mito-city
Mito, Ibaraki, 311-4145
Mito-city
Mito, Ibaraki, 319-0312
Miyakonojo-city
Miyakonojō, Miyazaki, 885-0055
Miyazaki-city
Miyazaki, Miyazaki, 889-1601
Moriguchi-city
Moriguchi, Osaka, 570-0074
Moriguchi-city
Moriguchi, Osaka, 570-0096
Morioka-city
Morioka, Iwate, 020-0023
Morioka-city
Morioka, Iwate, 020-0066
Morioka-city
Morioka, Iwate, 020-0831
Moriya-city
Moriya, Ibaraki, 302-0102
Moriyama-city
Moriyama, Shiga, 524-0022
Munakata-city
Munakata, Fukuoka, 811-3431
Muroran-city
Muroran, Hokkaido, 050-0076
Nagahama-city
Nagahama, Shiga, 526-0043
Nagakute-city
Nagakute, Aichi-ken, 480-1103
Nagano-city
Nagano, Nagano, 380-0928
Nagaoka-city
Nagaoka, Niigata, 940-2108
Nagasaki-city
Nagasaki, Nagasaki, 851-3101
Nagasaki-city
Nagasaki, Nagasaki, 852-8104
Nagasaki-city
Nagasaki, Nagasaki, 852-8125
Nagasaki-city
Nagasaki, Nagasaki, 852-8131
Nago-city
Nago, Okinawa, 905-0017
Nagoya-city
Nagoya, Aichi-ken, 453-0801
Nagoya-city
Nagoya, Aichi-ken, 457-0818
Nagoya-city
Nagoya, Aichi-ken, 460-0001
Nagoya-city
Nagoya, Aichi-ken, 464-0808
Nagoya-city
Nagoya, Aichi-ken, 466-0065
Nagoya-city
Nagoya, Aichi-ken, 466-0814
Nagoya-city
Nagoya, Aichi-ken, 467-0001
Nagoya-city
Nagoya, Aichi-ken, 468-0011
Naha-city
Naha, Okinawa, 902-0061
Naha-city
Naha, Okinawa, 902-0076
Nakagami-gun
Nakagami-gun, Okinawa, 903-0129
Nakatsu-city
Nakatsu, Oita Prefecture, 871-0011
Namegata-city
Namegata, Ibaraki, 311-3516
Nanao-city
Nanao, Ishikawa-ken, 926-0816
Nanao-city
Nanao, Ishikawa-ken, 926-0866
Nankoku-city
Nankoku, Kochi, 783-0043
Nara-city
Nara, Nara, 631-0805
Narita-city
Narita, Chiba, 286-0041
Naruto-city
Narutochō-mitsuishi, Tokushima, 772-0001
Natori-city
Natori-shi, Miyagi, 981-1239
Nemuro-city
Nemuro, Hokkaido, 087-0008
Nerima-ku
Nerima-ku, Tokyo, 177-0033
Neyagawa-city
Neyagawa, Osaka, 572-0022
Niigata-city
Niigata, Niigata, 950-0943
Niigata-city
Niigata, Niigata, 950-1141
Niigata-city
Niigata, Niigata, 951-8122
Niigata-city
Niigata, Niigata, 951-8133
Niiza-city
Niiza, Saitama, 352-0001
Ninohe-city
Ninohe, Iwate, 028-6105
Nishimuro-gun
Nishimuro-gun, Wakayama, 649-2621
Nishimuro-gun
Nishimuro-gun, Wakayama, 649-3142
Nishinomiya-city
Nishinomiya, Hyōgo, 662-0884
Nishinomiya-city
Nishinomiya, Hyōgo, 662-0918

Other trials in Japan

About this study

Official title: Agrylin Capsules 0.5 mg Drug Use-Result Survey

Read the detailed description

Anagrelide hydrochloride Drug Use-Result Survey

Conditions: Essential Thrombocythemia (ET)
Medical subject headings: Thrombocythemia, Essential

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03625895
Study group	Role	What they receive
Anagrelide hydrochloride		Participants who received treatment with Anagrelide hydrochloride will be evaluated for this study. Participants will receive interventions as part of routine medical care.

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Who Had One or More Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Measured: From start of study drug administration up to 12 months
Number of Participants Who Had One or More Serious Adverse Event
A serious AE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.
Measured: From start of study drug administration up to 12 months
Number of Participants Who Had One or More Adverse Drug Reactions
AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug.
Measured: From start of study drug administration up to 12 months
Number of Participants Who Had One or More Serious Adverse Drug Reactions
A serious AE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. Serious adverse drug reaction refers to serious AE that are related to administered drug.
Measured: From start of study drug administration up to 12 months
Percentage of Participants Who Responded in Platelet Count
Percentage of participants who responded in platelet count was assessed. A response was defined as platelet counts to <60 x10^4 platelet/mcrL beyond 3 months after the start of study drug administration.
Measured: From 3 months after the start of study drug administration, up to 12 months
Percentage of Participants With Normalization in Platelet Count
Percentage of participants with normalization in platelet count was assessed. Normalization was defined as platelet counts to <40 x10^4 platelets/mcrL beyond 3 months after the start of study drug administration.
Measured: From 3 months after the start of study drug administration, up to 12 months

Secondary outcomes (1)

Percentage of Participants With at Least 50% Reduction in Platelet Count
Participants who achieved at least 50% reduction in platelet count from their baseline during the 1-year observation period was assessed.
Measured: From start of study drug administration up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Nov 201411 Mar 2021

First posted10 Aug 2018
Study start25 Nov 2014
Primary completion11 Mar 2021
Study completion11 Mar 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Essential Thrombocythemia (ET)Studies of the same condition, open and under way.
More trials run by TakedaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 1,826 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03625895
Sponsor's protocol ID: SHP422-406
Status last verified: May 2022
First submitted: 8 Aug 2018
Last updated: 27 Feb 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
Hematology, IMG-7289, LSD1 (Lysine-Specific Demethylase 1) Inhibitor, Essential Thrombocythemia (ET), Ph 2
Thrombocythemia, Essential
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A Study of Bomedemstat (IMG-7289/MK-3543) Compared to Best Available Therapy (BAT) in Participants With Essential Thrombocythemia and an Inadequate Response or Intolerance of Hydroxyurea (MK-3543-006)
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All Essential Thrombocythemia (ET) trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Agrylin Capsules 0.5 mg Drug Use-Result Survey
ClinicalTrials.gov ID: NCT03625895
Acronym / sponsor ID: SHP422-406
Conditions: Essential Thrombocythemia (ET)
Study type: Observational
Recruitment status: Completed
Enrolment: 1,826 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 25 Nov 2014 (actual)
Primary completion: 11 Mar 2021 (actual)
Study completion: 11 Mar 2021 (actual)
First posted: 10 Aug 2018 (actual)
Results: Posted 27 Feb 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Anagrelide hydrochloride Drug Use-Result Survey

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Anagrelide hydrochloride	–	–Participants who received treatment with Anagrelide hydrochloride will be evaluated for this study. Participants will receive interventions as part of routine medical care.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Participants with essential thrombocythemia (ET) being treated with agrylin will be evaluated for this study.

Key inclusion criteria (1 listed)

All cases who received treatment with Agrylin.

Key exclusion criteria (1 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Number of Participants Who Had One or More Adverse Events
Time frame: From start of study drug administration up to 12 months
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Number of Participants Who Had One or More Serious Adverse Event
Time frame: From start of study drug administration up to 12 months
A serious AE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.
Number of Participants Who Had One or More Adverse Drug Reactions
Time frame: From start of study drug administration up to 12 months
AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug.
Number of Participants Who Had One or More Serious Adverse Drug Reactions
Time frame: From start of study drug administration up to 12 months
A serious AE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. Serious adverse drug reaction refers to serious AE that are related to administered drug.
Percentage of Participants Who Responded in Platelet Count
Time frame: From 3 months after the start of study drug administration, up to 12 months
Percentage of participants who responded in platelet count was assessed. A response was defined as platelet counts to <60 x10^4 platelet/mcrL beyond 3 months after the start of study drug administration.
Percentage of Participants With Normalization in Platelet Count
Time frame: From 3 months after the start of study drug administration, up to 12 months
Percentage of participants with normalization in platelet count was assessed. Normalization was defined as platelet counts to <40 x10^4 platelets/mcrL beyond 3 months after the start of study drug administration.

1 secondary outcome

Percentage of Participants With at Least 50% Reduction in Platelet Count
Time frame: From start of study drug administration up to 12 months

Results and safety

Results posted to the registry on 27 Feb 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Anagrelide Hydrochloride	1,826	1,241

Primary outcome: Number of Participants Who Had One or More Adverse Events

Time frame: From start of study drug administration up to 12 months. Count of participants. Unit: Participants

Measure	Anagrelide Hydrochloride n = 1241
Value	776

Population analysed: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.

Primary outcome: Number of Participants Who Had One or More Serious Adverse Event

Time frame: From start of study drug administration up to 12 months. Count of participants. Unit: Participants

Measure	Anagrelide Hydrochloride n = 1241
Value	234

Population analysed: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.

Primary outcome: Number of Participants Who Had One or More Adverse Drug Reactions

Time frame: From start of study drug administration up to 12 months. Count of participants. Unit: Participants

Measure	Anagrelide Hydrochloride n = 1241
Value	628

Population analysed: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.

Primary outcome: Number of Participants Who Had One or More Serious Adverse Drug Reactions

Time frame: From start of study drug administration up to 12 months. Count of participants. Unit: Participants

Measure	Anagrelide Hydrochloride n = 1241
Value	100

Population analysed: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From start of study drug administration up to 12 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Anagrelide Hydrochloride	234 of 1,241 (18.9%)	477 of 1,241 (38.4%)	47 of 1,241

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain more information on the study, click here/on this linkLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Related trials for Essential Thrombocythemia (ET)

Active, not recruitingPhase 2
Hematology, IMG-7289, LSD1 (Lysine-Specific Demethylase 1) Inhibitor, Essential Thrombocythemia (ET), Ph 2
Thrombocythemia, Essential
Not yet recruitingPhase 2
Flonoltinib Maleate Oral Regimens in Patients With Myelofibrosis
Myelofibrosis, Myelofibrosis Due to and Following Polycythemia Vera
Active, not recruitingPhase 3
A Study of Bomedemstat (IMG-7289/MK-3543) Compared to Best Available Therapy (BAT) in Participants With Essential Thrombocythemia and an Inadequate Response or Intolerance of Hydroxyurea (MK-3543-006)
Essential Thrombocythemia
Active, not recruitingPhase 1
Mutant CALR-peptide Based Vaccine in Patients With Mutated CALR Myeloproliferative Neoplasm
Myelofibrosis, Essential Thrombocythemia
Active, not recruitingPhase 1
Study of Pelabresib add-on to Ruxolitinib in Japanese Adult Patients With Myelofibrosis
Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis (Post-PV MF)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Study Director study director

Takeda

488 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Essential Thrombocythemia (ET), run by Takeda at 488 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 488 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Had One or More Adverse Events (time frame: From start of study drug administration up to 12 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03625895.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2023.