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shopee.tw/%3C³æ¤ù%3E-±d«Â·R±d½§±j¤Æ§l¦¬¿Ë¤ô©ÊÅÖºû¼Å®Æ-·Àµß-15cmx15cm-i.134360183.2235838604?gclid=EAIaIQobChMIpbWV44WD6gIVCRdgCh1-1Ai0EAYYASABEgKJMfD_BwE ConvaTecAQUACEL EXTRA Hydrofiber Dressing(Sterile)
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Experimental: ON101 Cream ON101 Cream (1.25%),15g ointment per tube. Twice daily for up to 16 weeks. Drug: ON101 Cream AquacelR HydrofiberR dressing AquacelR HydrofiberR dressings will be changed daily, on alternate days or three times a week according to need, but not longer than 7 days.
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Evaluate the Efficacy and Safety of ON101 Cream for the Treatment of Chronic Diabetic Foot Ulcers (ON101 (WH-1))
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating.Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01898923
Recruitment Status ƒÊ :Recruiting First Posted ƒÊ : July 15, 2013
Last Update Posted ƒÊ : January 22, 2020
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Sponsor:
Oneness Biotech Co., Ltd.
Information provided by (Responsible Party):
Oneness Biotech Co., Ltd.
Study Details Tabular View No Results Posted Disclaimer How to Read a Study Record
Study Description
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Brief Summary:
The primary objective of this study is to evaluate the efficacy of the new treatment of WH-1 ointment compared to Aquacel® Hydrofiber® dressing, applied to chronic diabetic foot ulcers for up to 16 weeks.An additional objective of this study is to collect safety information including adverse events and clinical laboratory abnormalities.
Condition or disease ƒÊ
Intervention/treatment ƒÊ
Phase ƒÊ
Diabetic Foot Drug: ON101 Cream
Other: Aquacel® Hydrofiber® dressing Phase 3
Detailed Description:
This trial is designed as a randomized, evaluator blinded, active-controlled, multi-center study comparing the efficacy and safety of WH-1 ointment and Aquacel® Hydrofiber® dressing in the treatment of diabetic foot ulcers. Independent evaluators who blinded to subjects¡¦ treatment will evaluate whether the wound has healed. Eligible subjects will be randomized to receive either WH-1 ointment or Aquacel® Hydrofiber® dressing in a 1:1 allocation. The study treatment will be applied to the selected ulcer for a maximum period of 16 weeks, until the wound/ulcer closure (wound size of 0) for two consecutive visits at least 2 weeks apart, or until the subject exited the study as treatment failure. After that, all subjects regardless of wound healing at the end of comparison period will be followed for 12 weeks to investigate durability. During the follow-up period, Aquacel® Hydrofiber® dressing will be applied for subjects who have unhealed or with recurrent wound. Each target ulcer with wound photographs for blind assessment will be monitored at each scheduled visit.
One interim analysis is planned at around 50% of study information; the final analysis will be conducted at the end of the study.
Study Design
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Study Type ƒÊ : Interventional (Clinical Trial) Estimated Enrollment ƒÊ : 236 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment Official Title: Randomized Controlled Study to Evaluate the Efficacy and Safety of ON101 Cream for the Treatment of Chronic Diabetic Foot Ulcers Study Start Date ƒÊ : September 2012 Estimated Primary Completion Date ƒÊ : June 2020 Estimated Study Completion Date ƒÊ : September 2020
Resource links provided by the National Library of Medicine
MedlinePlus related topics: Diabetic Foot Foot Health U.S. FDA Resources
Arms and Interventions
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Arm ƒÊ
Intervention/treatment ƒÊ
Experimental: ON101 Cream ON101 Cream (1.25%),15g ointment per tube. Twice daily for up to 16 weeks. Drug: ON101 Cream Aquacel® Hydrofiber® dressing Aquacel® Hydrofiber® dressings will be changed daily, on alternate days or three times a week according to need, but not longer than 7 days. Other: Aquacel® Hydrofiber® dressing
Outcome Measures
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Primary Outcome Measures ƒÊ : 1.The incidence of complete ulcer closure [ Time Frame: 16 weeks ]
The primary variable is the number of target ulcers healed in each group within 16 weeks. The primary efficacy outcome is the comparison of the incidence of complete healing of the target ulcer between the two treatment groups at the end of treatment.
For the purpose of this study a complete healing will be defined as complete epithelialization which is maintained with no drainage for at least 2 weeks and is confirmed by a blinded assessor.
Secondary Outcome Measures ƒÊ : 1.The time of healing rate [ Time Frame: 16 weeks ] Time to complete ulcer healing, The time of the original healing will be taken as the time to healing.
2.change in ulcer area [ Time Frame: 16 weeks ] Percentage change in ulcer surface area from baseline
3.50% reduction in ulcer area [ Time Frame: 16 weeks ] Percentage of subjects with a 50% reduction of ulcer surface area
4.Incidence of infection of the target ulcer [ Time Frame: 16 weeks ] Incidence of infection of the target ulcer
Eligibility Criteria
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Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: 20 Years to 80 Years (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria 1.Has signed a written informed consent prior to the first study evaluation; 2.Male or female is at least 20 and < 80 years of age; 3.Diabetes mellitus (type 1 or 2) with an HbA1c < 12.0% measured during screening or within three months prior to randomization; 4.An ankle brachial index on the target limb at least 0.8 measured during screening or within three months prior to randomization;
5.The target ulcer must have the following characteristics: ◦Grade 1 or 2 per Wagner Ulcer Classification System; ◦No higher than the ankle; ◦No active infected; ◦A cross-sectional area of between 1 and 25 cm2 post-debridement; ◦Present for at least 4 weeks before randomization;
6.If female and of childbearing potential has a negative pregnancy test and is not breastfeeding at screening visit; 7.Able and willing to attend the scheduled visits and comply with study procedures.
Exclusion Criteria: 1.Presence of necrosis, purulence or sinus tracts that cannot be removed by debridement; 2.Acute Charcot¡¦s neuroarthropathy as determined by clinical and/or radiographic examination; 3.Has undergone revascularization procedure aimed at increasing blood flow in the treatment target limb < 4 weeks prior to randomization; 4.Poor nutritional status defined as an albumin < 2.5 g/dL; 5.Aspartate Aminotransferase(AST, GOT) and/or Alanine Aminotransferase(ALT, GPT) >3 x the normal upper limit; 6.Serum Creatinine >2 x the normal upper limit; 7.Treatment with immunosuppressive or chemotherapeutic agents, radiotherapy or systemic corticosteroids less than 4 weeks before randomization; 8.Use of any investigational drug or therapy within the 4 weeks prior to randomization; 9.A psychiatric condition (e.g., suicidal ideation), current or chronic alcohol or drug abuse problem, determined from the subject¡¦s medical history, which, in the opinion of the Investigator, may pose a threat to subject compliance; 10.Judged by the investigator not to be suitable for the study for any other reason.
Contacts and Locations
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Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01898923
Contacts
Contact: Liu +886-2-2703-1098 ext 594
Locations Show Hide Hide 21 study locations
United States, California Limb Preservation Platform, Inc. Active, not recruiting Fresno, California, United States China, Guangdong Sun Yat-sen Memorial Hospital, Sun Yat-sen University Recruiting Guangzhou, Guangdong, China Nanfang Hospital of Southern Medical University Recruiting Guanzhou, Guangdong, China The First Affiliated Hospital, Sun Yat-sen University Recruiting Guanzhou, Guangdong, China China, Henan The First Affiliated Hospital of Henan Science & Technology University Recruiting Luoyang, Henan, China China, Jiangsu The First Affiliated Hospital of Soochow University Recruiting Suzhou, Jiangsu, China Affiliated Hospital of Jiangsu University Recruiting Zhenjiang, Jiangsu, China China, Shandong Shandong Provincial Hospital Recruiting Jinan, Shandong, China China, Shanghai Ruijin Hospital, Shanghai Jiaotong University School of Medicine Recruiting Shanghai, Shanghai, China Shanghai TCM-Interated Hospital Recruiting Shanghai, Shanghai, China Taiwan Chang Gung Medical Hospital_Kaohsiung Active, not recruiting Kaohsiung, Taiwan Buddhist Tzu Chi Medical Hospital Active, not recruiting New Taipei City, Taiwan MacKay Memorial Hospital-Tamsui Branch Active, not recruiting New Taipei City, Taiwan China Medical University Hospital Active, not recruiting Taichung City, Taiwan Chi Mei Medical Center-Yongkang Active, not recruiting Tainan City, Taiwan MacKay Memorial Hospital-Taipei Branch Active, not recruiting Taipei City, Taiwan National Taiwan University Hospital Active, not recruiting Taipei City, Taiwan Taipei Veterans General Hospital Active, not recruiting Taipei City, Taiwan Tri-Service General Hospital Active, not recruiting Taipei City, Taiwan Chang Gung Medical Hospital_Linkou Active, not recruiting Taoyuan City, Taiwan China Medical University Hospital-Beigang Branch Active, not recruiting Yunlin, Taiwan Sponsors and Collaborators
Oneness Biotech Co., Ltd.
More Information
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Responsible Party: Oneness Biotech Co., Ltd. ClinicalTrials.gov Identifier: NCT01898923 History of Changes Other Study ID Numbers: ON101CLCT02 First Posted: July 15, 2013 Key Record Dates Last Update Posted: January 22, 2020 Last Verified: January 2020 Keywords provided by Oneness Biotech Co., Ltd.:
WH-1,Diabetic Foot,Ulcer Additional relevant MeSH terms:
Diabetic Foot Foot Ulcer Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases Leg Ulcer Skin Ulcer Skin Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases Diabetic Neuropathies Foot Diseases Carboxymethylcellulose Sodium Laxatives Gastrointestinal Agents
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Lebrikizumab Phase 2b Study
The randomized, double-blind, placebo-controlled, parallel-group Phase 2b study was designed to evaluate the safety and efficacy of lebrikizumab as monotherapy compared with placebo and establish a dosing regimen for the Phase 3 program in patients with moderate-to-severe atopic dermatitis.
The study enrolled 280 patients ages 18 years and older with moderate-to-severe atopic dermatitis at 57 sites in the United States.
Three different lebrikizumab treatment dosing arms were evaluated, compared to a placebo arm, with patients randomized in a 3:3:3:2 fashion as follows:
• Group 1: A loading dose of 250 mg of lebrikizumab at baseline (day 0), followed by 125 mg of lebrikizumab every four weeks.
• Group 2: A loading dose of 500 mg of lebrikizumab at baseline (day 0), followed by 250 mg of lebrikizumab every four weeks.
• Group 3: A loading dose of 500 mg of lebrikizumab at baseline (day 0) and week 2, followed by 250 mg of lebrikizumab every two weeks.
• Group 4: Placebo at baseline (day 0) and every two weeks thereafter.
www.businesswire.com/news/home/20191017005896/en/Dermira-Presents-Data-Phase-2b-Study-Lebrikizumab
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phase2 -placebo-300mg/q2w/12 weeks n=61 1.EASI-50 29.5%(18/61=29.5%) 2.EASI-75 13.1%(8/61=13.1%) 3.EASI-90 3.3%(2/61=3.3%) 4.IGA 0/1 0%(0/61=0%)
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1.Lebrikizumab 2b ¤¤-««×AD Á{§Éªº«ü¼Ð(2019/3¤ë¤½¥¬)
(¤@).250 mg Q2W(¨â¶g¤@°w) EASI-50 81.0%*** EASI-75 60.6%*** EASI-90 44.0%*** IGA0/1 44.6%**
(¤G).250 mg Q4W(¥|¶g¤@°w) EASI-50 77.0%** EASI-75 56.1%** EASI-90 36.1%** IGA0/1 33.7%*
(¤T)¹ï·Ó²ÕPlacebo
EASI-50 45.8% EASI-75 24.3% EASI-90 11.4% IGA0/1 15.3%
*p<0.05, **p<0.01, and ***p<0.001 versus placebo www.businesswire.com/news/home/20191017005896/en/Dermira-Presents-Data-Phase-2b-Study-Lebrikizumab ------------ 2.1Dupliumab 3´Á ¤¤-««×AD, 2ÓSOLO1/SOLO2 Á{§Éªº«ü¼Ð(2016¦~¤½¥¬)
(¤@).300 mg Q2W(¨â¶g¤@°w/16¶g) EASI-50 65%/69% EASI-75 51%/44% EASI-90 36%/30% IGA0/1 38%/36%
(¤T)¹ï·Ó²ÕPlacebo
EASI-50 25%/22% EASI-75 15%/12% EASI-90 8%/7% IGA0/1 10%/8%
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Published: May 26, 2020 at 8:44 a.m. ET
By Jaimy Lee
Regeneron Pharmaceuticals Inc.¡]REGN¡^ªºªÑ²¼¦b©P¤G½L«e¥æ©ö¤¤¤Wº¦¤F0.4¢H¡A¸Ó¤½¥qªí¥Ü±N¦bÁÉ¿Õµá¡]Sanofi SNY¡^«Å¥¬±N¥¸¸ê50»õ¬ü¤¸¦^Áʨ䳡¤ÀªÑ²¼ªº²Ä¤G¤Ñ¡A -0.06¢H«Å¥¬¥X°â¨ä¦bRegeneronªº¤j³¡¤ÀªÑ¥÷¡C
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Shares of Regeneron Pharmaceuticals Inc. REGN, -4.33%were up 0.4% in premarket trading on Tuesday, the day after the company said it will spend $5 billion to buy back some of its own shares after Sanofi SNY, -0.06%announced it is selling most of its stake in Regeneron. Sanofi¡¦s stock had also gained 0.4% in premarket trading on Tuesday. While Sanofi¡¦s exit is occurring earlier than expected (agreement lock-up expires on Dec. 20, 2020, and liquidation was expected to take multiple years), we don¡¦t believe it will cause material disruption to REGN¡¦s stock, SVB Leerink¡¦s Geoffrey Porges wrote in a note to investors on Tuesday. Sanofi owns 23.2 million shares of Regeneron, a roughly 20% stake, and plans to sell 12.8 million shares. Regeneron will fund the buyback with $3.5 billion in cash and $1.5 billion in bridge financing. The French drugmaker had first made an investment in Regeneron in 2004; the two companies have also collaborated since 2003 on a number of Food and Drug Administration-approved therapies, including rheumatoid arthritis treatment Kevzara, PCSK9 inhibitor Praluent, and eczema drug Dupixent. Kevzara is currently in clinical trials testing the drug as a treatment for COVID-19 patients. The registered offering and share repurchase will have no impact on the ongoing collaboration between Regeneron and Sanofi, Regeneron said in a statement. Selling about 23 million shares in Regeneron may generate $13 billion in cash for Sanofi, setting the company up to make a mid-cap biotechnology deal, RBC Capital Markets analysts wrote on Monday. Since the start of the year, Sanofi¡¦s stock is down 5.4% and shares of Regeneron have gained 54.7%. The S&P 500 SPX, +1.22%is down 8.5%.
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Carl Firth³Õ¤h¬°§ù§J-·s¥[©Y°ê¤jÂå¾Ç°| (Duke-NUS Medical School) Ý¥ô±Ð±Â¡A¨Ã¾Ö¦³¼C¾ô¤j¾Ç¤T¤@¾Ç°|¤§¤À¤l¥Íª«¾Ç³Õ¤h¾Ç¦ì¡BÛ´°°Ó¾Ç°|ªºEMBA¥H¤Î¼C¾ô¤j¾Ç¤À¤l¥Íª«¾Ç¾Ç¦ì¡C |
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