OPKO公司完成生长激素缺乏患儿(hGH-CTP)的Somatrogon全球III期研究的入组

2018-08-05 MedSci MedSci原创

OPKO已完成在生长激素缺乏儿童的全球关键性第3阶段研究中的入组,评估其每周一次注射其研究的长效人类生长激素产品(somatrogon)。

OPKO已完成在生长激素缺乏儿童的全球关键性第3阶段研究中的入组,评估其每周一次注射其研究的长效人类生长激素产品(somatrogon)。somatrogonIII期试验是一项全球多中心、随机、开放标签的临床研究。这项研究招募了约225名患有生长激素缺乏症(GHD)的初治儿童,他们以11的比例随机分成两组:每周一次的somatrogon与每日一次的Genotropin。该试验的主要终点是52周时的身高,次要终点是安全性和药效学。

Somatrogon是一种新的分子实体,它保留了生长激素的天然序列,同时C末端肽融合到天然序列以延长其半衰期。在一项II期儿科试验中,生长激素缺乏的儿童每周注射一次somatrogon,患儿可以产生类似于日常生长激素替代疗法的药效学效果,具有相当的疗效和安全性。在正在进行的扩展中证实了somatrogon的长期安全性和中和抗体的缺乏。Somatrogon已在美国和欧盟获得Orphan Drug认定用于治疗患有GHD的儿童和成人。


原始出处:

http://www.firstwordpharma.com/node/1583054?tsid=4#axzz5NCMJrdAy

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    2019-12-09 ms8011528410028227

    国内金赛长效生长激素早2年就应用于临床了,小编应该多了解一点

    0

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    2018-09-01 juliusluan78
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    2018-10-27 陆成振
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    2019-01-06 whlxd
  7. [GetPortalCommentsPageByObjectIdResponse(id=376724, encodeId=63583e67248a, content=国内金赛长效生长激素早2年就应用于临床了,小编应该多了解一点, beContent=null, objectType=article, channel=null, level=null, likeNumber=58, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=86ec1792862, createdName=ms8011528410028227, createdTime=Mon Dec 09 08:37:35 CST 2019, time=2019-12-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1916030, encodeId=1e281916030db, content=<a href='/topic/show?id=c5a89550ff' target=_blank style='color:#2F92EE;'>#III#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9550, encryptionId=c5a89550ff, topicName=III)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e68e415, createdName=juliusluan78, createdTime=Sat Sep 01 12:29:00 CST 2018, time=2018-09-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1946199, encodeId=ba47194619965, content=<a href='/topic/show?id=cbb816545ca' target=_blank style='color:#2F92EE;'>#somatrogon#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=21, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16545, encryptionId=cbb816545ca, topicName=somatrogon)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=docwu2019, createdTime=Thu Jul 18 10:29:00 CST 2019, time=2019-07-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1759095, encodeId=955a1e590957e, content=<a href='/topic/show?id=c23c1342087' target=_blank style='color:#2F92EE;'>#OPKO#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=20, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13420, encryptionId=c23c1342087, topicName=OPKO)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=5ce837418812, createdName=陆成振, createdTime=Sat Oct 27 09:29:00 CST 2018, time=2018-10-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2021339, encodeId=a162202133968, content=<a href='/topic/show?id=69d595e421' target=_blank style='color:#2F92EE;'>#III期研究#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9574, encryptionId=69d595e421, topicName=III期研究)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/qXbLjJB4FSzhQS3C5qQFMJkqicRIJFL6zHFwwhv0I95nzA6xicevQcEica0gk4A58UkbMMriadAgTY2b7N7Yd0ZsQg/132, createdBy=910c2500152, createdName=HinsMax, createdTime=Thu Sep 27 13:29:00 CST 2018, time=2018-09-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1647799, encodeId=5fc1164e799c7, content=<a href='/topic/show?id=a0d954329f' target=_blank style='color:#2F92EE;'>#CTP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=5432, encryptionId=a0d954329f, topicName=CTP)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ab3223492864, createdName=whlxd, createdTime=Sun Jan 06 02:29:00 CST 2019, time=2019-01-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1407464, encodeId=ab95140e4648f, content=<a href='/topic/show?id=a79569632f4' target=_blank style='color:#2F92EE;'>#生长激素缺乏#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=69632, encryptionId=a79569632f4, topicName=生长激素缺乏)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a3fa2654160, createdName=lidong41, createdTime=Tue Aug 07 03:29:00 CST 2018, time=2018-08-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1594529, encodeId=c0f01594529d2, content=<a href='/topic/show?id=b317956200' target=_blank style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=22, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9562, encryptionId=b317956200, topicName=III期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Tue Aug 07 03:29:00 CST 2018, time=2018-08-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=336639, encodeId=7fec3366396c, content=好, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0aa31415219, createdName=orangesking, createdTime=Sun Aug 05 13:15:05 CST 2018, time=2018-08-05, status=1, ipAttribution=)]
  8. [GetPortalCommentsPageByObjectIdResponse(id=376724, encodeId=63583e67248a, content=国内金赛长效生长激素早2年就应用于临床了,小编应该多了解一点, beContent=null, objectType=article, channel=null, level=null, likeNumber=58, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=86ec1792862, createdName=ms8011528410028227, createdTime=Mon Dec 09 08:37:35 CST 2019, time=2019-12-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1916030, encodeId=1e281916030db, content=<a href='/topic/show?id=c5a89550ff' target=_blank style='color:#2F92EE;'>#III#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9550, encryptionId=c5a89550ff, topicName=III)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e68e415, createdName=juliusluan78, createdTime=Sat Sep 01 12:29:00 CST 2018, time=2018-09-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1946199, encodeId=ba47194619965, content=<a href='/topic/show?id=cbb816545ca' target=_blank style='color:#2F92EE;'>#somatrogon#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=21, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16545, encryptionId=cbb816545ca, topicName=somatrogon)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=docwu2019, createdTime=Thu Jul 18 10:29:00 CST 2019, time=2019-07-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1759095, encodeId=955a1e590957e, content=<a href='/topic/show?id=c23c1342087' target=_blank style='color:#2F92EE;'>#OPKO#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=20, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13420, encryptionId=c23c1342087, topicName=OPKO)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=5ce837418812, createdName=陆成振, createdTime=Sat Oct 27 09:29:00 CST 2018, time=2018-10-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2021339, encodeId=a162202133968, content=<a href='/topic/show?id=69d595e421' target=_blank style='color:#2F92EE;'>#III期研究#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9574, encryptionId=69d595e421, topicName=III期研究)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/qXbLjJB4FSzhQS3C5qQFMJkqicRIJFL6zHFwwhv0I95nzA6xicevQcEica0gk4A58UkbMMriadAgTY2b7N7Yd0ZsQg/132, createdBy=910c2500152, createdName=HinsMax, createdTime=Thu Sep 27 13:29:00 CST 2018, time=2018-09-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1647799, encodeId=5fc1164e799c7, content=<a href='/topic/show?id=a0d954329f' target=_blank style='color:#2F92EE;'>#CTP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=5432, encryptionId=a0d954329f, topicName=CTP)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ab3223492864, createdName=whlxd, createdTime=Sun Jan 06 02:29:00 CST 2019, time=2019-01-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1407464, encodeId=ab95140e4648f, content=<a href='/topic/show?id=a79569632f4' target=_blank style='color:#2F92EE;'>#生长激素缺乏#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=69632, encryptionId=a79569632f4, topicName=生长激素缺乏)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a3fa2654160, createdName=lidong41, createdTime=Tue Aug 07 03:29:00 CST 2018, time=2018-08-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1594529, encodeId=c0f01594529d2, content=<a href='/topic/show?id=b317956200' target=_blank style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=22, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9562, encryptionId=b317956200, topicName=III期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Tue Aug 07 03:29:00 CST 2018, time=2018-08-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=336639, encodeId=7fec3366396c, content=好, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0aa31415219, createdName=orangesking, createdTime=Sun Aug 05 13:15:05 CST 2018, time=2018-08-05, status=1, ipAttribution=)]
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    2018-08-05 orangesking

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