hepatitis b immune globulin (human)
Trade name: BayHep B
Biologicalapproved
Approved
Sep 23, 1977
Clinical trial activity
30 trials · 69 clinical orgs · 3 marketing orgs
Phase 1
2
Phase 2
19
Phase 3
13
Phase 4
5
Earliest trial started Nov 1, 1999 (NCT01421212)
Timeline
1970s
1990s
- Jan 1, 1999
Earliest Phase 1 Sponsor(trial)
2000s
- Jan 1, 2000
Earliest Phase 3 Sponsor(trial)
- Oct 23, 2001
ADMA Biologics, Inc. — NDA Secondary Org
- Jan 1, 2004
- Jan 27, 2006
Kamada, Ltd. — NDA Secondary Org
Indications
Approved for
Studied for
- Cardiovascular Diseases · Phase 3
- Coronary Disease · Phase 3
- Diabetes Mellitus · Phase 3
- Diabetes Mellitus, Type 2 · Phase 3
- Healthy Volunteers · Phase 1
- Heart Diseases · Phase 3
- Hepatitis B · Phase 4
- Hepatitis B, Chronic · Phase 3
- Insulin Resistance · Phase 3
- Liver Transplantation · Phase 4
- Lung Transplantation · Phase 2
Mechanism of action
- Surface antigen (HBsAg)BINDING AGENT
Surface antigen (HBsAg) binding agent
- Hepatitis B virusImmunity, passive
Hepatitis B virus immunity, passive
Approval history
- approvedSep 23, 1977
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
Oral
No
Parenteral
No
Topical
No
Sources
- NCATSXII270YC6M ↗
- ChEMBLCHEMBL2108512 ↗
Also known as
- anti-hepatitis b immunoglobulin
- bayhep b
- bayhep b
- biguanide
- biguanide
- biguanide
- bioguanide
- bt088 immunoglobulin, human
- hbig
- hbig
- hbig
- hbig
- h-big
- hepabulin
- hepagam b
- hepatitis b hyperimmune globulin
- hepatitis b immune globulin
- hepatitis b immune globulin
- hepatitis b immune globulin (human)
- hepatitis b immune globulin (human)
- hepatitis b immunoglobulin
- hepatitis b virus immune globulin
- hep-b-gammagee
- human hepatitis b immunoglobulin
- human hepatitis b immunoglobulin
- human hepatitis-b immunoglobulin
- human hepatitis-b immunoglobulin
- human hepatitis b virus immune globulin
- human hepatitis b virus immune globulin
- human hepatitis b virus immune globulin
- liberim hb
- zutectra
- zutectra
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT05293158 | N/A | Jan 31, 2023 | Medical University of Graz |
| NCT05686759 | Phase 3 | Jan 18, 2023 | Green Cross Corporation |
| NCT05404919 | Phase 2 | Sep 6, 2022 | University of Pennsylvania |
| NCT05345990 | Phase 2 | Aug 15, 2022 | Biotest Pharmaceuticals, Gottfried Wilhelm Leibniz Universität Hannover, Hannover Medical School |
| NCT03899142 | Phase 1 | Jan 28, 2019 | Sanquin |
| NCT03575208 | Phase 2 | Oct 5, 2018 | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| NCT03519113 | Phase 2/Phase 3 (Phase 3) | Mar 29, 2018 | Green Cross Corporation, University of Ulsan |
| NCT02417207 | Phase 4 | Apr 1, 2015 | Sun Yat-Sen University |
| NCT01940965 | Phase 3 | Sep 1, 2013 | Sanofi |
| NCT01777282 | Phase 3 | Feb 23, 2013 | GlaxoSmithKline |
| NCT01856413 | Phase 3 | Dec 1, 2012 | Advanced Medical Services GmbH, Biotest Pharmaceuticals, Hopital Paul Brousse |
| NCT02312531 | N/A | May 1, 2012 | Jiao Tong University |
| NCT01584232 | Phase 3 | Apr 1, 2012 | Eli Lilly |
| NCT01468181 | Phase 3 | Nov 1, 2011 | Eli Lilly |
| NCT01301833 | Phase 3 | Feb 1, 2011 | Mitsubishi Tanabe, University of Tokyo |
| NCT01513850 | Phase 3 | Oct 1, 2010 | Catholic University of Korea, SK Chemicals |
| NCT01131065 | Phase 3 | Jul 1, 2010 | Grifols |
| NCT00800787 | Phase 3 | Apr 1, 2010 | Biotest Pharmaceuticals, Sponsor GmbH |
| NCT00998426 | Phase 4 | Oct 1, 2009 | Cangene, Georgetown University |
| NCT00846716 | N/A | Mar 1, 2008 | Ako City Hospital, Horide Clinic, Hyogo Medical University, Kanazawa University, Kawabata Clinic, Kohka Public Hospital, Nagahama City Hospital, Nagahama Red Cross Hospital, NTT West Osaka Hospital, Omihachiman COmmunity Medical Center, Osaka University, Sawada Clinic, Second Okamoto General Hospital, Shiga Clinic, Shiga Hospital, Shiga University, Tomita Clinic, Toyosato Hospital, Tsukiwa-machi, Seta, Otsu, Shiga, Japan, Yasu Hospital |
Showing 20 of 30 trials
Page 1 / 2
Organizations
Research & Development (69)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Biotest Pharmaceuticals | For profit | 4 | 3 | 2 | 1999 |
| Grifols | For profit | 3 | 3 | 2 | 2003 |
| Cangene | For profit | 2 | 1 | 1 | 2008 |
| Eli Lilly | For profit | 2 | 2 | 1 | 2011 |
| GlaxoSmithKline | For profit | 2 | 2 | 2 | 2003 |
| Green Cross Corporation | For profit | 2 | 2 | 1 | 2018 |
| Mayo Clinic | Academic/Hospital | 2 | 0 | 2 | 1999 |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Government | 2 | 1 | 2 | 2000 |
| Advanced Medical Services GmbH | Academic/Hospital | 1 | 0 | 1 | 2012 |
| Ako City Hospital | Academic/Hospital | 1 | 0 | 1 | 2008 |
| Catholic University of Korea | Academic/Hospital | 1 | 0 | 1 | 2010 |
| Columbia University | Academic/Hospital | 1 | 0 | 1 | 1999 |
| Cubist | For profit | 1 | 1 | 1 | 2005 |
| Georgetown University | Academic/Hospital | 1 | 1 | 1 | 2009 |
| Gilead Sciences | For profit | 1 | 1 | 1 | 2007 |
| Gottfried Wilhelm Leibniz Universität Hannover | Academic/Hospital | 1 | 1 | 1 | 2022 |
| Govind Ballabh Pant Institute of Postgraduate Medical Education and Research | Academic/Hospital | 1 | 1 | 1 | 2005 |
| Hannover Medical School | Academic/Hospital | 1 | 0 | 1 | 2022 |
| Hopital Paul Brousse | Academic/Hospital | 1 | 0 | 1 | 2012 |
| Horide Clinic | Academic/Hospital | 1 | 0 | 1 | 2008 |
69 organizations
Page 1 / 4
Marketing (4)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| ADMA Biologics, Inc. | For profit | NDA2 | Oct 23, 2001 |
| Grifols | For profit | NDA2 | Sep 23, 1977 |
| Grifols | For profit | NDA | Sep 23, 1977 |
| Kamada, Ltd. | For profit | NDA2 | Jan 27, 2006 |